# Braemar, Inc.

- Location (FDA's records): Burnsville, MN
- FDA decisions: 10 (1995–2008): 10 510(k) clearances
- Names in FDA's records: Braemar, Inc. (5); Braemar Corp. (5)
- Product codes: MWJ (6), DRG (1), DXH (1), DSI (1), DSH (1)
- Predicates its devices cite: 6 (2 its own); citations of its devices by later devices: 26 (2 its own)
- Recalls linked to its devices: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Biosensor Corp.: 3 (https://510kreport.com/company/biosensor)
- Tz Medical, Inc.: 1 (https://510kreport.com/company/tz-medical)

## Firms that cite its devices most
- Intricon Datrix Corporation: 3 (https://510kreport.com/company/intricon-datrix)
- Datrix: 2 (https://510kreport.com/company/datrix)
- Ela Medical, Inc.: 2 (https://510kreport.com/company/ela-medical)
- Scottcare Corporation: 2 (https://510kreport.com/company/scottcare)
- Memtec Corp.: 1 (https://510kreport.com/company/memtec)
- Platinum Team Co., Ltd.: 1 (https://510kreport.com/company/platinum-team)
- Braemar Manufacturing, LLC: 1 (https://510kreport.com/company/braemar-manufacturing)
- Tom Medical Entwicklungs GmbH: 1 (https://510kreport.com/company/tom-medical-entwicklungs)

## Its most-cited devices
- K993617: Digitrakplus Holter Recorder (1999), cited by 7
- K993618: DXP1000 Holter Recorder (1999), cited by 6
- K981394: Braemar ER700 Series Ambulatory Ecg Event Monitor Models ER710,ER720 (1998), cited by 3
- K071733: DL900 Series Holter Recorder (2007), cited by 2
- K081444: Braemar Fusion Wireless - Ambulatory Ecg Arrhythmia Monitoring System (2008), cited by 2
- K945130: Braemar Model DL700 Ambulatory Electrocardiographic Recorder (1995), cited by 2

## Recent decisions
- K081444: Braemar Fusion Wireless - Ambulatory Ecg Arrhythmia Monitoring System (Jul 31, 2008)
- K072008: Braemar ER900 Wireless Series Arrhythmia Event Recorder (Oct 3, 2007)
- K071733: DL900 Series Holter Recorder (Jul 24, 2007)
- K071011: Modification to: Braemar ER900 Series Enhanced Algorithm Ecg Event Recorder (Apr 27, 2007)
- K042469: Braemar ER800 Series Enhanced Algorithm Event Recorder (Oct 6, 2004)
- K030856: ER800 Series Ecg Event Recorder (Mar 28, 2003)
- K993617: Digitrakplus Holter Recorder (Nov 24, 1999)
- K993618: DXP1000 Holter Recorder (Nov 24, 1999)

Source page: https://510kreport.com/company/braemar