Braemar, Inc.
Medical device manufacturer in Eagan, MN.
10510(k) clearances
0PMA approvals
2recalls
Device types
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K081444 | Braemar Fusion Wireless - Ambulatory ECG Arrhythmia Monitoring SystemDSI · Traditional | 07/31/2008SE |
| K072008 | Braemar ER900 Wireless Series Arrhythmia Event RecorderDRG · Traditional | 10/03/2007SE |
| K071733 | DL900 Series Holter RecorderMWJ · Special | 07/24/2007SE |
| K071011 | Modification to: Braemar ER900 Series Enhanced Algorithm ECG Event RecorderMWJ · Special | 04/27/2007SE |
| K042469 | Braemar ER800 Series Enhanced Algorithm Event RecorderMWJ · Traditional | 10/06/2004SE |
| K030856 | ER800 Series ECG Event RecorderMWJ · Special | 03/28/2003SE |
| K993618 | DXP1000 Holter RecorderMWJ · Special | 11/24/1999SE |
| K993617 | Digitrakplus Holter RecorderMWJ · Special | 11/24/1999SE |
| K981394 | Braemar ER700 Series Ambulatory ECG Event Monitor Models ER710,ER720DXH · Traditional | 09/28/1998SE |
| K945130 | Braemar Model DL700 Ambulatory Electrocardiographic RecorderDSH · Traditional | 04/12/1995SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-1652-2013 Class II | Lithium Thionyl non-rechargeable disposable battery pack P/N 350-0294-01 used with ER920…Braemar has recently became aware of a battery related incident that occurred with EWT battery packs that… | 02/24/2012Terminated |
| Z-1645-2013 Class II | Lithium Thionyl non-rechargeable disposable battery pack P/N 350-0294-00 used with ER920…Braemar Inc., became aware of a battery related incident that occurred with an Able battery pack being used… | 05/02/2011Terminated |