510(k) K960972

DISPOSABLE GAS SAMPLING INTERFACE KITS by Marquest Medical Products, Inc. — Product Code CCK

K960972 is an FDA 510(k) premarket notification submitted by Marquest Medical Products, Inc. for the device "DISPOSABLE GAS SAMPLING INTERFACE KITS". The FDA issued a decision of Substantially Equivalent on October 18, 1996. The device falls under product code CCK (Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase), a Class II device regulated under 21 CFR 868.1400. Marquest Medical Products, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 18, 1996
Date Received
March 11, 1996
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