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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 K884330
Device Name MODEL 463 ELECTROCARDIORECORDER RECORDER
Applicant
Del Mar Avionics
1621 Alton Pkwy.
Irvine,  CA  92606
Applicant Contact J SUNDHEIMER
Correspondent
Del Mar Avionics
1621 Alton Pkwy.
Irvine,  CA  92606
Correspondent Contact J SUNDHEIMER
Regulation Number870.2800
Classification Product Code
DSH  
Date Received10/14/1988
Decision Date 01/05/1989
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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