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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 K792076
Device Name MODEL 448 PACERCORDER
Applicant
Del Mar Avionics
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Del Mar Avionics
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number870.2800
Classification Product Code
DSH  
Date Received10/15/1979
Decision Date 12/27/1979
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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