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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ventilator, Continuous, Facility Use
510(k) Number K162832
Device Name 731 Series Ventilators
Applicant
ZOLL MEDICAL CORPORATION
269 & 271 MILL ROAD
CHELMSFORD,  MA  01824 -4105
Applicant Contact CHUCK KOLIFRATH
Correspondent
ZOLL MEDICAL CORPORATION
269 & 271 MILL ROAD
CHELMSFORD,  MA  01824 -4105
Correspondent Contact CHUCK KOLIFRATH
Regulation Number868.5895
Classification Product Code
CBK  
Subsequent Product Code
DQA  
Date Received10/11/2016
Decision Date 08/02/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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