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510(k) K162832

731 Series Ventilators by ZOLL Medical Corporation — Product Code CBK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 2, 2017
Date Received
October 11, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ventilator, Continuous, Facility Use
Device Class
Class II
Regulation Number
868.5895
Review Panel
AN
Submission Type

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