510(k) K143150

CO2 monitoring line with and without in-line filter by Besmed Health Business Corp — Product Code CCK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 5, 2015
Date Received
November 3, 2014
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