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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 K233486
Device Name 731 Series Ventilator
Applicant
ZOLL Medical Corporation
269 Mill Rd.
Chelsmford,  MA  01824
Applicant Contact Jeffrey Churchill
Correspondent
ZOLL Medical Corporation
269 Mill Rd.
Chelsmford,  MA  01824
Correspondent Contact Jeffrey Churchill
Regulation Number868.5895
Classification Product Code
CBK  
Subsequent Product Code
DQA  
Date Received10/27/2023
Decision Date 12/13/2024
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
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