510(k) K072008 ยท DRG Transmitters And Receivers, Physiological Signal, Radiofrequency
BRAEMAR ER900 WIRELESS SERIES ARRHYTHMIA EVENT RECORDER
| Applicant | Braemar, Inc., Eagan MN, US |
| Decision | Substantially Equivalent, Oct 3, 2007 |
| Received | Jul 23, 2007 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K072008
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| 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 | None listed |
| 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 | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.