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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 K990762
Device Name ZOLL M SERIES WITH RECTILINEAR BI-PHASIC OPTION (M SERIES BI-PHASIC)
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  
Subsequent Product Codes
DPS   DRO   LDD  
Date Received03/08/1999
Decision Date 09/03/1999
Decision SE SUBJECT TO TRACKING REG (ST)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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