510(k) K910019

NOVAMETRIX MODEL 1265 END TIDAL CARBON DIOXIDE MON by Novametrix Medical Systems, Inc. — Product Code CCK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 26, 1991
Date Received
January 3, 1991
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