METROPOLIS INTERNATIONAL, LLC

FDA Device Registration & Listing · Long Island City, NY, US · Registration 3005877899

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3005877899
FEI Number
3005877899
Entity Name
METROPOLIS INTERNATIONAL, LLC
City/State/Country
Long Island City, NY, US
Establishment Address
38-13 10th Street, Long Island City, NY 11101, US
Establishment Type(s)
Repack or Relabel Medical Device
Owner / Operator
Metropolis International, LLC (Owner Number: 10043887)
Owner / Operator Contact Address
38-13 10th street, Long Island City, NY 11101, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Metropolis International Metropolis International Metropolis International Metropolis International Metropolis International Metropolis International Siemens Healthineers Metropolis International Metropolis International Metropolis International Metropolis International Metropolis International Metropolis International Metropolis International Metropolis International Metropolis International Metropolis International Metropolis International Metropolis International Metropolis International Metropolis International Metropolis International Metropolis International Metropolis International Metropolis International Metropolis International Metropolis International Metropolis International Metropolis International Metropolis International Metropolis International Metropolis International Metropolis International

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) Cardiovascular Class 2 870.1025 2023-12-14
JAA System, X-Ray, Fluoroscopic, Image-Intensified Radiology Class 2 892.1650 2024-11-25
OXO Image-Intensified Fluoroscopic X-Ray System, Mobile Radiology Class 2 892.1650 2024-11-25
MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) Cardiovascular Class 2 870.1025 2023-12-14
OXO Image-Intensified Fluoroscopic X-Ray System, Mobile Radiology Class 2 892.1650 2023-05-23
OWB Interventional Fluoroscopic X-Ray System Radiology Class 2 892.1650 2023-05-23
JAA System, X-Ray, Fluoroscopic, Image-Intensified Radiology Class 2 892.1650 2023-05-23
JAK System, X-Ray, Tomography, Computed Radiology Class 2 892.1750 2025-03-31
JAA System, X-Ray, Fluoroscopic, Image-Intensified Radiology Class 2 892.1650 2021-07-15
OWB Interventional Fluoroscopic X-Ray System Radiology Class 2 892.1650 2021-07-15
OXO Image-Intensified Fluoroscopic X-Ray System, Mobile Radiology Class 2 892.1650 2021-07-15
MUE Full Field Digital, System, X-Ray, Mammographic Radiology Class 2 892.1715 2024-05-20
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2024-10-22
JAK System, X-Ray, Tomography, Computed Radiology Class 2 892.1750 2024-10-22
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2021-12-17
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2021-12-17
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2021-12-17
IZI System, X-Ray, Angiographic Radiology Class 2 892.1600 2023-09-21
JAA System, X-Ray, Fluoroscopic, Image-Intensified Radiology Class 2 892.1650 2023-09-21
OWB Interventional Fluoroscopic X-Ray System Radiology Class 2 892.1650 2023-09-21
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2025-04-18
DQA Oximeter Cardiovascular Class 2 870.2700 2023-12-13
DRT Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) Cardiovascular Class 2 870.2300 2023-12-13
ORT Burst Suppression Detection Software For Electroencephalograph Neurology Class 2 882.1400 2023-12-13
DSK Computer, Blood-Pressure Cardiovascular Class 2 870.1110 2023-12-13
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2023-12-13
OLW Index-Generating Electroencephalograph Software Neurology Class 2 882.1400 2023-12-13
DSJ Alarm, Blood-Pressure Cardiovascular Class 2 870.1100 2023-12-13
DPS Electrocardiograph Cardiovascular Class 2 870.2340 2023-12-13
OLT Non-Normalizing Quantitative Electroencephalograph Software Neurology Class 2 882.1400 2023-12-13
DPZ Oximeter, Ear Cardiovascular Class 2 870.2710 2023-12-13
NHP Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration) Anesthesiology Class 2 868.1500 2023-12-13
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2023-12-13
DSI Detector And Alarm, Arrhythmia Cardiovascular Class 2 870.1025 2023-12-13
MLD Monitor, St Segment With Alarm Cardiovascular Class 2 870.1025 2023-12-13
CCL Analyzer, Gas, Oxygen, Gaseous-Phase Anesthesiology Class 2 868.1720 2023-12-13
BZK Spirometer, Monitoring (W/Wo Alarm) Anesthesiology Class 2 868.1850 2023-12-13
GWQ Full-Montage Standard Electroencephalograph Neurology Class 2 882.1400 2023-12-13
BZQ Monitor, Breathing Frequency Anesthesiology Class 2 868.2375 2023-12-13
KRB Probe, Thermodilution Cardiovascular Class 2 870.1915 2023-12-13
CBS Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.) Anesthesiology Class 2 868.1620 2023-12-13
MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) Cardiovascular Class 2 870.1025 2023-12-13
CBR Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.) Anesthesiology Class 2 868.1700 2023-12-13
OMC Reduced- Montage Standard Electroencephalograph Neurology Class 2 882.1400 2023-12-13
GWJ Stimulator, Auditory, Evoked Response Neurology Class 2 882.1900 2023-12-13
CBQ Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration) Anesthesiology Class 2 868.1500 2023-12-13
DQK Computer, Diagnostic, Programmable Cardiovascular Class 2 870.1425 2023-12-13
BZL Computer, Oxygen-Uptake Anesthesiology Class 2 868.1730 2023-12-13
DXG Computer, Diagnostic, Pre-Programmed, Single-Function Cardiovascular Class 2 870.1435 2023-12-13
KOI Stimulator, Nerve, Peripheral, Electric Anesthesiology Class 2 868.2775 2023-12-13
CAP Monitor, Airway Pressure (Includes Gauge And/Or Alarm) Anesthesiology Class 2 868.2600 2023-12-13
CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase Anesthesiology Class 2 868.1400 2023-12-13
NHQ Analyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic Concentration) Anesthesiology Class 2 868.1500 2023-12-13
NHO Analyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration) Anesthesiology Class 2 868.1500 2023-12-13
IZL System, X-Ray, Mobile Radiology Class 2 892.1720 2021-07-29
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2021-12-17
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2021-12-17
LLZ System, Image Processing, Radiological Radiology Class 2 892.2050 2021-12-17
OIJ Biopsy Needle Guide Kit Radiology Class 2 892.1560 2021-12-17
OBJ Catheter, Ultrasound, Intravascular Cardiovascular Class 2 870.1200 2021-12-17
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2021-12-17
GWJ Stimulator, Auditory, Evoked Response Neurology Class 2 882.1900 2023-12-14
GWQ Full-Montage Standard Electroencephalograph Neurology Class 2 882.1400 2023-12-14
KOI Stimulator, Nerve, Peripheral, Electric Anesthesiology Class 2 868.2775 2023-12-14
KRB Probe, Thermodilution Cardiovascular Class 2 870.1915 2023-12-14
CBQ Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration) Anesthesiology Class 2 868.1500 2023-12-14
NHP Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration) Anesthesiology Class 2 868.1500 2023-12-14
OLT Non-Normalizing Quantitative Electroencephalograph Software Neurology Class 2 882.1400 2023-12-14
DQK Computer, Diagnostic, Programmable Cardiovascular Class 2 870.1425 2023-12-14
BZL Computer, Oxygen-Uptake Anesthesiology Class 2 868.1730 2023-12-14
DPS Electrocardiograph Cardiovascular Class 2 870.2340 2023-12-14
BZQ Monitor, Breathing Frequency Anesthesiology Class 2 868.2375 2023-12-14
ORT Burst Suppression Detection Software For Electroencephalograph Neurology Class 2 882.1400 2023-12-14
MLD Monitor, St Segment With Alarm Cardiovascular Class 2 870.1025 2023-12-14
MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) Cardiovascular Class 2 870.1025 2023-12-14
OLW Index-Generating Electroencephalograph Software Neurology Class 2 882.1400 2023-12-14
DSK Computer, Blood-Pressure Cardiovascular Class 2 870.1110 2023-12-14
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2023-12-14
DSJ Alarm, Blood-Pressure Cardiovascular Class 2 870.1100 2023-12-14
DRT Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) Cardiovascular Class 2 870.2300 2023-12-14
CAP Monitor, Airway Pressure (Includes Gauge And/Or Alarm) Anesthesiology Class 2 868.2600 2023-12-14
CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase Anesthesiology Class 2 868.1400 2023-12-14
CBR Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.) Anesthesiology Class 2 868.1700 2023-12-14
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2023-12-14
OMC Reduced- Montage Standard Electroencephalograph Neurology Class 2 882.1400 2023-12-14
NHQ Analyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic Concentration) Anesthesiology Class 2 868.1500 2023-12-14
CCL Analyzer, Gas, Oxygen, Gaseous-Phase Anesthesiology Class 2 868.1720 2023-12-14
DSI Detector And Alarm, Arrhythmia Cardiovascular Class 2 870.1025 2023-12-14
NHO Analyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration) Anesthesiology Class 2 868.1500 2023-12-14
CBS Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.) Anesthesiology Class 2 868.1620 2023-12-14
DXG Computer, Diagnostic, Pre-Programmed, Single-Function Cardiovascular Class 2 870.1435 2023-12-14
DQA Oximeter Cardiovascular Class 2 870.2700 2023-12-14
DPZ Oximeter, Ear Cardiovascular Class 2 870.2710 2023-12-14
BZK Spirometer, Monitoring (W/Wo Alarm) Anesthesiology Class 2 868.1850 2023-12-14
MUE Full Field Digital, System, X-Ray, Mammographic Radiology Class 2 892.1715 2022-02-01
JAK System, X-Ray, Tomography, Computed Radiology Class 2 892.1750 2022-05-13
IZL System, X-Ray, Mobile Radiology Class 2 892.1720 2021-07-15
JAK System, X-Ray, Tomography, Computed Radiology Class 2 892.1750 2025-04-18
KPS System, Tomography, Computed, Emission Radiology Class 2 892.1200 2025-04-18
JAK System, X-Ray, Tomography, Computed Radiology Class 2 892.1750 2025-04-29
JAK System, X-Ray, Tomography, Computed Radiology Class 2 892.1750 2025-02-06
JAA System, X-Ray, Fluoroscopic, Image-Intensified Radiology Class 2 892.1650 2024-10-22
OXO Image-Intensified Fluoroscopic X-Ray System, Mobile Radiology Class 2 892.1650 2024-10-22
OWB Interventional Fluoroscopic X-Ray System Radiology Class 2 892.1650 2024-10-22
MOS Coil, Magnetic Resonance, Specialty Radiology Class 2 892.1000 2022-09-08
LNI System, Nuclear Magnetic Resonance Spectroscopic Radiology Class 2 892.1000 2022-09-08
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2022-09-08
LLZ System, Image Processing, Radiological Radiology Class 2 892.2050 2025-04-29
JAK System, X-Ray, Tomography, Computed Radiology Class 2 892.1750 2025-04-29
LNI System, Nuclear Magnetic Resonance Spectroscopic Radiology Class 2 892.1000 2023-08-08
MOS Coil, Magnetic Resonance, Specialty Radiology Class 2 892.1000 2023-08-08
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2023-08-08
JAK System, X-Ray, Tomography, Computed Radiology Class 2 892.1750 2022-03-23
IZI System, X-Ray, Angiographic Radiology Class 2 892.1600 2025-04-29
LLZ System, Image Processing, Radiological Radiology Class 2 892.2050 2024-09-26
MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) Cardiovascular Class 2 870.1025 2023-12-14
IZL System, X-Ray, Mobile Radiology Class 2 892.1720 2021-11-24
ITY Assembly, Tube Housing, X-Ray, Diagnostic Radiology Class 1 892.1760 2022-02-15

Official Correspondent

Leon Gugel

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Metropolis International, LLC
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K993974 Siemens Medical Solutions USA, Inc. SIEMENS INFINITY SC 6002XL PORTABLE PATIENT MONITOR 2000-02-22
K182075 Shenzhen Mindray Bio-Medical Electronics Co., Ltd. BeneVision N Series Patient Monitors (Including BeneVision N12, BeneVision N15, BeneVision N17, BeneVision N19. BeneVision N22, BeneVision N1) 2018-12-10
K051628 Draeger Medical Systems, Inc. INFINITY MONITORS WITH SCIO MODIFICATIONS 2005-07-20
K972535 Odam MAGLIFE C 1998-01-13
K170567 Remote Diagnostic Technologies , Ltd. Tempus Pro Patient Monitor 2017-07-06

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0020-2025 Philips North America Llc 2
IntelliVue Patient Monitor MX400/MX450/MX500/MX550 with software version P.01.01 and ordered with Option CP2 are affected as follows: 1) IntelliVue MX400 866060; 2) IntelliVue MX450 866062; 3) IntelliVue MX500 866064; 4) IntelliVue MX550 866066 Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients.
Z-1027-2026 Remote Diagnostic Technologies Ltd. Farnborough Aerospace Centre Aerospace Boulevard Farnborough United Kingdom 2
Philips Tempus Pro Patient Monitor, REF: 00-1004, 00-1007, 00-1004-R, 00-1007-R, 00-1024-R, 00-1026-R. USB 2-Channel IBP Module, REF: 01-2017. Used with User/Operator Manual
Z-1321-2023 Remote Diagnostic Technologies Ltd. Farnborough Aerospace Centre Aerospace Boulevard Farnborough United Kingdom 2
Tempus Pro Patient Monitor is a portable vital signs monitor intended to be used by clinicians and medically qualified personnel, for the attended or unattended monitoring of single or multiple vital signs in clinical and pre hospital care applications. The affected power supplies are related to the following Tempus Pro Patient Monitoring units: Model Numbers: 00-1004 00-1004-R 00-1007 00-1007-R 00-1024-R 00-1026-R Model Numbers: 00-1004 00-1004-R 00-1007 00-1007-R 00-1024-R 00-1026-R
Z-1666-2025 Remote Diagnostic Technologies Ltd. Farnborough Aerospace Centre Aerospace Boulevard Farnborough United Kingdom 2
Tempus Pro Patient Monitor, REFs: 00-1004-R (Tempus Pro non-printer, IBP, without headset dock), 00-1007-R and 00-1007 (Tempus Pro non-printer, IBP, with headset dock), 00-1024-R (Tempus Pro printer), 00-1026-R (Tempus Pro printer, IBP), 00-1007 [(Tempus Pro, BT Dock (IB Only)], 00-1004 00-1004 [Tempus Pro (IB Only)]
Z-1729-2025 Remote Diagnostic Technologies Ltd. Farnborough Aerospace Centre Aerospace Boulevard Farnborough United Kingdom 2
Philips Tempus Pro Patient Monitor, REF: 00-1004-R, 00-1007-R, 00-1024-R, 00-1026-R, 00-1004, 00-1007

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005877899. Last updated year: 2026. Please use registration number 3005877899 when referencing this establishment in official correspondence.
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