Panels › Cardiovascular › Product code DRG · Class 2
Transmitters And Receivers, Physiological Signal, Radiofrequency
Regulation 870.2910
2510(k)s in 12 months (192 all time)
1recalls in 12 months (12 all time)
12recalls that name a 510(k)
Top companies in DRG
| Company | 510(k)s | Recalls |
|---|---|---|
| Vitalconnect, Inc. | 9 | 1 |
| Honeywell Hommed | 6 | 0 |
| Nihon Kohden America, Inc. | 5 | 1 |
| American Telecare, Inc. | 5 | 0 |
| General Devices | 5 | 0 |
| Bl Healthcare, Inc. | 4 | 0 |
| Health Hero Network, Inc. | 4 | 0 |
| Lifesignals, Inc. | 4 | 0 |
| Philips Medical Systems | 4 | 0 |
| Biointellisense, Inc. | 2 | 1 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 25, 2026 | Midmark Corporation Midmark Digital ECG HD+12, HD+15, Model/Catalog Number: 4-000-0080
Software Version: Midmark IQecg Plugin versions starting with v10 and prior to v10.1.0.18. Open, Classified |
DRG | K220526 |
| Aug 14, 2024 | Biointellisense Inc. BioButton REF BIOST06040 with Software version 3.0.20
The BioButton System is a remote monitoring wearable device intended for continuous collection of physiological data in home and healthcare setti Open, Classified |
DRG | K212957 |
| Jan 8, 2021 | Nihon Kohden America Inc WMTS Telemetry Receiver, Multiple Patient Receiver, Model Number/ UDI:
ORG 9100A/ 00841983102554
ORG 9110A/ 00841983102561
ORG 9700A/No UDI Open, Classified |
DRG | K071058 |
| Jul 10, 2020 | Vitalconnect Inc. VistaSolution, physiological signal transmitter. A software graphical user interface for use by healthcare professionals to display physiological data collected by the wireless remote monitoring syst Terminated |
DRG | K193343 |
| May 15, 2017 | Boston Scientific Corporation FFR Link-FFR Signal Processing Module, Material Number H7495551000
It is intended to condition physiological signals from measuring devices (BSC Pressure Guidewire or an external pressure transducer) Terminated |
DRG | K170204 |
| Mar 2, 2017 | Philips Visicu eCare Coordinator
Product Usage: is software intended for use in data aggregation, patient interaction facilitation, storage and clinical information management with independent physiological devic Terminated |
DRG | K141706 |
| Mar 10, 2016 | Philips Visicu eCareCoordinator allows the customer to schedule patient tasks (i.e., take weight measurement, take blood pressure).
For medical use by professional medical staff. Terminated |
DRG | K141706 |
| Jul 2, 2013 | BRAEMAR, INC. Lithium Thionyl non-rechargeable disposable battery pack P/N 350-0294-00 used with ER920 Wireless Series Arrhythmia Event Recorder.
Non-rechargeable disposable battery pack. Terminated |
DRG | K072008 |
| Jul 2, 2013 | BRAEMAR, INC. Lithium Thionyl non-rechargeable disposable battery pack P/N 350-0294-01 used with ER920 Wireless Series Arrhythmia Event Recorder.
Non-rechargeable disposable battery pack. Terminated |
DRG | K072008 |
| Sep 16, 2008 | Lifesync Corporation LS-202 Large LeadWear Combo Pack - Disposable ECG Monitoring component intended for use as a radiofrequency signal transmitter and receiver of electrocardiograph physiological signals which are displa Terminated |
DRG | K030795 |
| Sep 16, 2008 | Lifesync Corporation LS-232 Large 12 LeadWear Single Pack - Disposable ECG Monitoring component intended for use as a radiofrequency signal transmitter and receiver of electrocardiograph physiological signals which are di Terminated |
DRG | K030795 |
| Feb 27, 2007 | GMP Companies/Lifesync Corporation LifeSync ECG System - Disposable leadwear, Ls-222, Ls-223 Terminated |
DRG | K030795 |
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