Braemar, Inc.
Braemar, Inc. holds FDA 510(k) medical device clearances, first cleared 2004, most recent 2008, with 2 FDA device recalls on record.
Top product codes for Braemar, Inc.
FDA recalls by Braemar, Inc.
- Z-1652-2013 — 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.
- Z-1645-2013 — 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.
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Braemar, Inc.
- K081444 — BRAEMAR FUSION WIRELESS - AMBULATORY ECG ARRHYTHMIA MONITORING SYSTEM
- K072008 — BRAEMAR ER900 WIRELESS SERIES ARRHYTHMIA EVENT RECORDER
- K071733 — DL900 SERIES HOLTER RECORDER
- K071011 — MODIFICATION TO: BRAEMAR ER900 SERIES ENHANCED ALGORITHM ECG EVENT RECORDER
- K042469 — BRAEMAR ER800 SERIES ENHANCED ALGORITHM EVENT RECORDER
Data sourced from openFDA. This site is unofficial and independent of the FDA.