510(k) K942113

CARBON DIOXIDE ANALYZER (MODEL CD-3A) by Ametek, Inc. — Product Code CCK

K942113 is an FDA 510(k) premarket notification submitted by Ametek, Inc. for the device "CARBON DIOXIDE ANALYZER (MODEL CD-3A)". The FDA issued a decision of Substantially Equivalent on February 16, 1995. The device falls under product code CCK (Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase), a Class II device regulated under 21 CFR 868.1400. Ametek, Inc. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 16, 1995
Date Received
May 2, 1994
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