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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 K010257
Device Name ZOLL M SERIES
Applicant
ZOLL MEDICAL CORP.
32 SECOND AVE.
BURLINGTON,  MA  01803
Applicant Contact PAUL DIAS
Correspondent
ZOLL MEDICAL CORP.
32 SECOND AVE.
BURLINGTON,  MA  01803
Correspondent Contact PAUL DIAS
Regulation Number870.5310
Classification Product Code
MKJ  
Date Received01/29/2001
Decision Date 02/28/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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