510(k) K040847

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

K040847 is an FDA 510(k) premarket notification submitted by Draeger Medical, Inc. for the device "MODIFICATION TO VAMOS ANESTHETIC GAS MONITOR". The FDA issued a decision of Substantially Equivalent on June 17, 2004. 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
June 17, 2004
Date Received
April 1, 2004
Clearance Type
Special
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