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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Transmitters And Receivers, Electrocardiograph, Telephone
510(k) Number K971696
Device Name SENTINEL RECORDER, MODELS 471/472
Applicant
Del Mar Avionics
1621 Alton Pkwy.
Irvine,  CA  92606 -4801
Applicant Contact RAPHAEL HENKIN
Correspondent
Del Mar Avionics
1621 Alton Pkwy.
Irvine,  CA  92606 -4801
Correspondent Contact RAPHAEL HENKIN
Regulation Number870.2920
Classification Product Code
DXH  
Date Received05/08/1997
Decision Date 12/30/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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