Company ยท US
Braemar Corp.
FDA 510(k) clearances and medical device recalls filed under this name, 1995 to 2008. Name variants (Inc, Corp, punctuation) are merged.
10510(k) clearances (0 in 12 months)
2recalls (0 in 12 months)
2recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 31, 2008 | K081444 | BRAEMAR FUSION WIRELESS - AMBULATORY ECG ARRHYTHMIA MONITORING SYSTEM Braemar, Inc. | DSI |
| Oct 3, 2007 | K072008 | BRAEMAR ER900 WIRELESS SERIES ARRHYTHMIA EVENT RECORDER Braemar, Inc. | DRG |
| Jul 24, 2007 | K071733 | DL900 SERIES HOLTER RECORDER Braemar, Inc. | MWJ |
| Apr 27, 2007 | K071011 | MODIFICATION TO: BRAEMAR ER900 SERIES ENHANCED ALGORITHM ECG EVENT RECORDER Braemar, Inc. | MWJ |
| Oct 6, 2004 | K042469 | BRAEMAR ER800 SERIES ENHANCED ALGORITHM EVENT RECORDER Braemar, Inc. | MWJ |
| Mar 28, 2003 | K030856 | ER800 SERIES ECG EVENT RECORDER Braemar Corp. | MWJ |
| Nov 24, 1999 | K993618 | DXP1000 HOLTER RECORDER Braemar Corp. | MWJ |
| Nov 24, 1999 | K993617 | DIGITRAKPLUS HOLTER RECORDER Braemar Corp. | MWJ |
| Sep 28, 1998 | K981394 | BRAEMAR ER700 SERIES AMBULATORY ECG EVENT MONITOR MODELS ER710,ER720 Braemar Corp. | DXH |
| Apr 12, 1995 | K945130 | BRAEMAR MODEL DL700 AMBULATORY ELECTROCARDIOGRAPHIC RECORDER Braemar Corp. | DSH |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| 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 |