510(k) K012139

VAMOS ANESTHETIC GAS MONITOR by Draeger Medical, Inc. — Product Code CCK

K012139 is an FDA 510(k) premarket notification submitted by Draeger Medical, Inc. for the device "VAMOS ANESTHETIC GAS MONITOR". The FDA issued a decision of Substantially Equivalent on January 17, 2002. The device falls under product code CCK (Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase), a Class II device regulated under 21 CFR 868.1400. Draeger Medical, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 17, 2002
Date Received
July 10, 2001
Clearance Type
Abbreviated
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