510(k) K233486

731 Series Ventilator by ZOLL Medical Corporation — Product Code CBK

K233486 is an FDA 510(k) premarket notification submitted by ZOLL Medical Corporation for the device "731 Series Ventilator". The FDA issued a decision of Substantially Equivalent on December 13, 2024. The device falls under product code CBK (Ventilator, Continuous, Facility Use), a Class II device regulated under 21 CFR 868.5895. ZOLL Medical Corporation has at least 10 other 510(k) clearances on record.

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