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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name automated external defibrillators (non-wearable)
510(k) Number K942344
Device Name ZOLL PD 1600 SEMI-AUTOMATIC EXTERNAL DEFIBRILLATOR
Applicant
ZOLL MEDICAL CORP.
32 SECOND AVE.
BURLINGTON,  MA  01803
Applicant Contact OLGA CHERNIAVSKY
Correspondent
ZOLL MEDICAL CORP.
32 SECOND AVE.
BURLINGTON,  MA  01803
Correspondent Contact OLGA CHERNIAVSKY
Regulation Number870.5310
Classification Product Code
MKJ  
Date Received05/16/1994
Decision Date 03/13/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
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