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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Recorder, Magnetic Tape, Medical
510(k) Number K945130
Device Name BRAEMAR MODEL DL700 AMBULATORY ELECTROCARDIOGRAPHIC RECORDER
Applicant
Braemar Corp.
11481 Rupp Dr.
Burnsville,  MN  55337
Applicant Contact DAVE NORBERG
Correspondent
Braemar Corp.
11481 Rupp Dr.
Burnsville,  MN  55337
Correspondent Contact DAVE NORBERG
Regulation Number870.2800
Classification Product Code
DSH  
Date Received10/19/1994
Decision Date 04/12/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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