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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 K895793
Device Name MICROPOTENTIAL ANALYZER/SPECTROCARDIOGRAPHY OPTION
Applicant
Del Mar Avionics
1621 Alton Pkwy.
Irvine,  CA  92606
Applicant Contact BILL SUNDHEIMER
Correspondent
Del Mar Avionics
1621 Alton Pkwy.
Irvine,  CA  92606
Correspondent Contact BILL SUNDHEIMER
Regulation Number870.2800
Classification Product Code
DSH  
Date Received09/28/1989
Decision Date 02/13/1990
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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