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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrocardiograph, Ambulatory (Without Analysis)
510(k) Number K071011
Device Name MODIFICATION TO: BRAEMAR ER900 SERIES ENHANCED ALGORITHM ECG EVENT RECORDER
Applicant
Braemar, Inc.
1285 Corporate Center Dr.
Suite 150
Eagan,  MN  55121
Applicant Contact DARREN DERSHEM
Correspondent
Braemar, Inc.
1285 Corporate Center Dr.
Suite 150
Eagan,  MN  55121
Correspondent Contact DARREN DERSHEM
Regulation Number870.2800
Classification Product Code
MWJ  
Date Received04/10/2007
Decision Date 04/27/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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