ZOLL Manufacturing Corporation

FDA Device Registration & Listing · Pittsburgh, PA, US · Registration 3008642652

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
3008642652
FEI Number
3008642652
Entity Name
ZOLL Manufacturing Corporation
City/State/Country
Pittsburgh, PA, US
Establishment Address
121 Gamma Dr, Pittsburgh, PA 15238, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
ZOLL Manufacturing Corporation (Owner Number: 9045611)
Owner / Operator Contact Address
121 GAMMA DRIVE, --, Pittsburgh, PA 15238, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K190939
PMA Number
N/A

All Registered Proprietary Names

uCor Heart Failure and Arrhythmia Management System ZOLL ECG Analysis Software ZOLL Arrhythmia Management System

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 2018-05-22
DSB Plethysmograph, Impedance Cardiovascular Class 2 870.2770 2018-05-22
DSI Detector And Alarm, Arrhythmia Cardiovascular Class 2 870.1025 2018-05-22
DPS Electrocardiograph Cardiovascular Class 2 870.2340 2019-02-22
DSI Detector And Alarm, Arrhythmia Cardiovascular Class 2 870.1025 2020-07-24
MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) Cardiovascular Class 2 870.1025 2020-07-24

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

ZOLL Manufacturing Corporation
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 3008642652. Last updated year: 2026. Please use registration number 3008642652 when referencing this establishment in official correspondence.
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