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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name system, measurement, blood-pressure, non-invasive
510(k) Number K002029
Device Name ZOLL M SERIES NIBP OPTION, MODEL MSERIES NIBP 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 Number870.1130
Classification Product Code
DXN  
Date Received07/03/2000
Decision Date 09/21/2000
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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