BRAEMAR, INC.
FDA Regulatory Profile
BRAEMAR, INC. appears in FDA public data with 2 recalls, 10 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-1652-2013, Class II) was initiated on February 24, 2012. Its most recent 510(k) clearance was granted on July 31, 2008.
Summary
- Total Recalls
- 2
- 510(k) Clearances
- 10
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1652-2013 | Class II | Lithium Thionyl non-rechargeable disposable battery pack P/N 350-0294-01 used with ER920 Wireless Se | February 24, 2012 |
| Z-1645-2013 | Class II | Lithium Thionyl non-rechargeable disposable battery pack P/N 350-0294-00 used with ER920 Wireless Se | May 2, 2011 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K081444 | BRAEMAR FUSION WIRELESS - AMBULATORY ECG ARRHYTHMIA MONITORING SYSTEM | July 31, 2008 |
| K072008 | BRAEMAR ER900 WIRELESS SERIES ARRHYTHMIA EVENT RECORDER | October 3, 2007 |
| K071733 | DL900 SERIES HOLTER RECORDER | July 24, 2007 |
| K071011 | MODIFICATION TO: BRAEMAR ER900 SERIES ENHANCED ALGORITHM ECG EVENT RECORDER | April 27, 2007 |
| K042469 | BRAEMAR ER800 SERIES ENHANCED ALGORITHM EVENT RECORDER | October 6, 2004 |
| K030856 | ER800 SERIES ECG EVENT RECORDER | March 28, 2003 |
| K993618 | DXP1000 HOLTER RECORDER | November 24, 1999 |
| K993617 | DIGITRAKPLUS HOLTER RECORDER | November 24, 1999 |
| K981394 | BRAEMAR ER700 SERIES AMBULATORY ECG EVENT MONITOR MODELS ER710,ER720 | September 28, 1998 |
| K945130 | BRAEMAR MODEL DL700 AMBULATORY ELECTROCARDIOGRAPHIC RECORDER | April 12, 1995 |