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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 K932028
Device Name PD-1400 PACER/DEFIBRILLATOR
Applicant
ZOLL MEDICAL CORP.
500 WEST CUMMINGS PARK
WOBURN,  MA  01801
Applicant Contact GARY FREEMAN
Correspondent
ZOLL MEDICAL CORP.
500 WEST CUMMINGS PARK
WOBURN,  MA  01801
Correspondent Contact GARY FREEMAN
Regulation Number870.5310
Classification Product Code
MKJ  
Date Received04/26/1993
Decision Date 10/08/1993
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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