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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
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