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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tester, Defibrillator
510(k) Number K896985
Device Name ZAP-GUARD
Applicant
Guardian Angel Products, Inc.
Suite 202
2617 Huntingdon Pike
Huntingdon Valley,  PA  19006
Applicant Contact MICHAEL N BUSS
Correspondent
Guardian Angel Products, Inc.
Suite 202
2617 Huntingdon Pike
Huntingdon Valley,  PA  19006
Correspondent Contact MICHAEL N BUSS
Regulation Number870.5325
Classification Product Code
DRL  
Date Received12/13/1989
Decision Date 07/31/1990
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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