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BRAEMAR, INC.

FDA Regulatory Profile

Summary

Total Recalls
2
510(k) Clearances
10
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1652-2013Class IILithium Thionyl non-rechargeable disposable battery pack P/N 350-0294-01 used with ER920 Wireless SeFebruary 24, 2012
Z-1645-2013Class IILithium Thionyl non-rechargeable disposable battery pack P/N 350-0294-00 used with ER920 Wireless SeMay 2, 2011

Recent 510(k) Clearances

K-NumberDeviceDate
K081444BRAEMAR FUSION WIRELESS - AMBULATORY ECG ARRHYTHMIA MONITORING SYSTEMJuly 31, 2008
K072008BRAEMAR ER900 WIRELESS SERIES ARRHYTHMIA EVENT RECORDEROctober 3, 2007
K071733DL900 SERIES HOLTER RECORDERJuly 24, 2007
K071011MODIFICATION TO: BRAEMAR ER900 SERIES ENHANCED ALGORITHM ECG EVENT RECORDERApril 27, 2007
K042469BRAEMAR ER800 SERIES ENHANCED ALGORITHM EVENT RECORDEROctober 6, 2004
K030856ER800 SERIES ECG EVENT RECORDERMarch 28, 2003
K993617DIGITRAKPLUS HOLTER RECORDERNovember 24, 1999
K993618DXP1000 HOLTER RECORDERNovember 24, 1999
K981394BRAEMAR ER700 SERIES AMBULATORY ECG EVENT MONITOR MODELS ER710,ER720September 28, 1998
K945130BRAEMAR MODEL DL700 AMBULATORY ELECTROCARDIOGRAPHIC RECORDERApril 12, 1995