510(k) K873149

NOVAMETRIX END TIDAL CO2 MONITOR, MODEL 1260 by Novametrix Medical Systems, Inc. — Product Code CCK

K873149 is an FDA 510(k) premarket notification submitted by Novametrix Medical Systems, Inc. for the device "NOVAMETRIX END TIDAL CO2 MONITOR, MODEL 1260". The FDA issued a decision of Substantially Equivalent on November 6, 1987. The device falls under product code CCK (Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase), a Class II device regulated under 21 CFR 868.1400. Novametrix Medical Systems, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 6, 1987
Date Received
August 11, 1987
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