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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 K991556
Device Name ZOLL M SERIES 12SL ANALYSIS OPTION
Applicant
ZOLL MEDICAL CORP.
32 SECOND AVE.
BURLINGTON,  MA  01803 -4420
Applicant Contact PAUL DIAS
Correspondent
ZOLL MEDICAL CORP.
32 SECOND AVE.
BURLINGTON,  MA  01803 -4420
Correspondent Contact PAUL DIAS
Regulation Number870.5310
Classification Product Code
MKJ  
Date Received05/04/1999
Decision Date 10/21/1999
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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