510(k) K063813

VENTLAB NASAL CO2 SAMPLING/O2 DELIVERY CANNULA by Ventlab Corp. — Product Code CCK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 26, 2008
Date Received
December 22, 2006
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