Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010390468

FEI Number

3010390468

Entity Name

MEDISONO, LLC

City/State/Country

Doral, FL, US

Establishment Address

3016 NW 82nd Ave, Doral, FL 33122, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

Medisono, LLC (Owner Number: 10044902)

Owner / Operator Contact Address

3016 NW 82nd Ave, Doral, FL 33122, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K151787

PMA Number

N/A

All Registered Proprietary Names

MM12 Patient Monitor MEDISONO Brand Mediblu, BLU12 Patient Monitor MEDISONO Brand Mediblu, MM1 Patient Monitor MEDISONO Ultrasound System FM02 Fetal Monitor MEDISONO Brand Mediblu MO1 Pulse Oximeter MEDISONO Brand Mediblu Video Endoscope System Video Endoscope System P11, P11 EXPERT, P12 Trolley, P12 Expert, P25 Trolley,P25 Expert Trolley Medisono Ultrasound System Ultrasound System Central Patient Monitor System CMS4 MEDISONO Brand Mediblu FD1 Ultrasonic Pocket Doppler MEDISONO Brand Mediblu MB15 Patient Monitor MEDISONO Brand Mediblu, MB12 Patient Monitor MEDISONO Brand Mediblu MBV1 Vital Signs Monitor MEDISONO Brand Mediblu MM3 VITAL SIGNS MONITOR MEDISONO Brand Mediblu MS12 Digital Color Doppler Ultrasound System Medisono Ultrasound System Medisono Ultrasound System MS55 Plus, P25 Expert, P12 Plus, P11 Plus, P9 Plus P3 Plus MEDISONO Ultrasound Diagnostic System Ultrasound System Blood Pressure Holter System HA5P MEDISONO Brand Mediblu Ultrasound System Ultrasound System Ultrasound System Video Colposcope DVC300 MEDISONO Brand Mediblu Ultrasound System Ultrasound System P1, P3, P10 Medisono Ultraspund System Ultrasound System Sony UPD898MD UPX898MD Graphic Printers Ultrasound System ECG MEDISONO Brand Mediblu ME3, ME6, ME12P, ME15P HA3P HOLTER SYSTEM MEDISONO Brand Mediblu

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	2018-12-12
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2019-05-06
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2019-05-06
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2019-05-06
HGM	System, Monitoring, Perinatal	Obstetrics/Gynecology	Class 2	884.2740	2026-04-14
HGL	Transducer, Ultrasonic, Obstetric	Obstetrics/Gynecology	Class 2	884.2960	2026-04-14
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2018-12-12
FDS	Gastroscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2023-08-07
NWB	Endoscope, Accessories, Narrow Band Spectrum	Gastroenterology, Urology	Class 2	876.1500	2023-08-07
FDF	Colonoscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2023-08-07
FDF	Colonoscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2023-08-07
FDS	Gastroscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2023-08-07
NWB	Endoscope, Accessories, Narrow Band Spectrum	Gastroenterology, Urology	Class 2	876.1500	2023-08-07
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2017-06-13
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2017-06-13
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2017-06-13
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2021-12-07
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2021-12-07
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2021-12-07
HGM	System, Monitoring, Perinatal	Obstetrics/Gynecology	Class 2	884.2740	2026-04-09
DPW	Flowmeter, Blood, Cardiovascular	Cardiovascular	Class 2	870.2100	2026-04-14
KNG	Monitor, Ultrasonic, Fetal	Obstetrics/Gynecology	Class 2	884.2660	2026-04-14
DRT	Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)	Cardiovascular	Class 2	870.2300	2026-04-09
MHX	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.1025	2026-04-09
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2026-04-09
BZQ	Monitor, Breathing Frequency	Anesthesiology	Class 2	868.2375	2026-04-09
CCK	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	Anesthesiology	Class 2	868.1400	2026-04-09
DSI	Detector And Alarm, Arrhythmia	Cardiovascular	Class 2	870.1025	2026-04-09
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2026-04-09
DSK	Computer, Blood-Pressure	Cardiovascular	Class 2	870.1110	2026-04-09
CCL	Analyzer, Gas, Oxygen, Gaseous-Phase	Anesthesiology	Class 2	868.1720	2026-04-09
MLD	Monitor, St Segment With Alarm	Cardiovascular	Class 2	870.1025	2026-04-09
DPS	Electrocardiograph	Cardiovascular	Class 2	870.2340	2026-04-09
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2026-04-09
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2026-04-09
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2026-04-09
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2026-04-09
MWI	Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.2300	2026-04-09
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2026-04-14
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2026-04-14
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2026-04-14
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2022-09-09
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2022-09-09
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2022-09-09
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2023-07-20
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2023-07-20
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2023-07-20
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2023-08-03
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2023-08-03
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2023-08-03
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2025-07-01
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2025-07-01
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2025-07-01
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2023-07-20
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2023-07-20
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2023-07-20
MLO	Electrocardiograph, Ambulatory, With Analysis Algorithm	Cardiovascular	Class 2	870.2800	2026-04-09
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2020-08-26
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2020-08-26
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2020-08-26
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2023-05-03
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2023-05-03
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2023-05-03
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2019-09-10
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2019-09-10
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2019-09-10
HEX	Colposcope (And Colpomicroscope)	Obstetrics/Gynecology	Class 2	884.1630	2026-04-09
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2023-07-20
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2023-07-20
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2023-07-20
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2019-04-11
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2019-04-11
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2019-04-11
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2017-06-13
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2017-06-13
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2017-06-13
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2023-07-20
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2023-07-20
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2023-07-20
LMC	Camera, Multi Format, Radiological	Radiology	Class 2	892.2040	2026-05-19
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2022-09-29
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2022-09-29
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2022-09-29
DPS	Electrocardiograph	Cardiovascular	Class 2	870.2340	2026-04-09
DQK	Computer, Diagnostic, Programmable	Cardiovascular	Class 2	870.1425	2026-04-14
MWJ	Electrocardiograph, Ambulatory (Without Analysis)	Cardiovascular	Class 2	870.2800	2026-04-14

Official Correspondent

Monica Felitto

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Medisono, 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 3010390468. Last updated year: 2026. Please use registration number 3010390468 when referencing this establishment in official correspondence.