510(k) K233486

731 Series Ventilator by ZOLL Medical Corporation — Product Code CBK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 13, 2024
Date Received
October 27, 2023
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