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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Detector And Alarm, Arrhythmia
510(k) Number K811122
Device Name DEL MAR AVIONICS MODELS 9400 & 9401
Applicant
DEL MAR AVIONICS
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
DEL MAR AVIONICS
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number870.1025
Classification Product Code
DSI  
Date Received04/24/1981
Decision Date 06/12/1981
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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