510(k) K162832

731 Series Ventilators by ZOLL Medical Corporation — Product Code CBK

K162832 is an FDA 510(k) premarket notification submitted by ZOLL Medical Corporation for the device "731 Series Ventilators". The FDA issued a decision of Substantially Equivalent on August 2, 2017. 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
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