510(k) K162343

Westmed Gas Sampling Cannula with O2 delivery by Westmed, Inc. — Product Code CCK

K162343 is an FDA 510(k) premarket notification submitted by Westmed, Inc. for the device "Westmed Gas Sampling Cannula with O2 delivery". The FDA issued a decision of Substantially Equivalent on December 14, 2016. The device falls under product code CCK (Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase), a Class II device regulated under 21 CFR 868.1400. Westmed, Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 14, 2016
Date Received
August 22, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
Device Class
Class II
Regulation Number
868.1400
Review Panel
AN
Submission Type