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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 K990027
Device Name OMNICORDER, MODEL 464
Applicant
Del Mar Avionics
1621 Alton Pkwy.
Irvine,  CA  92606
Applicant Contact RAPHAEL HENKIN
Correspondent
Del Mar Avionics
1621 Alton Pkwy.
Irvine,  CA  92606
Correspondent Contact RAPHAEL HENKIN
Regulation Number870.2800
Classification Product Code
DSH  
Date Received01/05/1999
Decision Date 02/09/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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