510(k) K874036

MODEL 7000 COMBINATION END TIDAL & PULSE OXIMETRY by Novametrix Medical Systems, Inc. — Product Code CCK

K874036 is an FDA 510(k) premarket notification submitted by Novametrix Medical Systems, Inc. for the device "MODEL 7000 COMBINATION END TIDAL & PULSE OXIMETRY". 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
October 5, 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