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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 K993036
Device Name ZOLL M SERIES ETCO2 OPTION
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 Code
CCK  
Date Received09/09/1999
Decision Date 02/28/2000
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
Predetermined Change
Control Plan Authorized		 No
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