510(k) K943824

GASEOUS OXYGEN ANALYZER (MODEL S-3A) MODIFICATION by Ametek, Inc. — Product Code CCL

K943824 is an FDA 510(k) premarket notification submitted by Ametek, Inc. for the device "GASEOUS OXYGEN ANALYZER (MODEL S-3A) MODIFICATION". The FDA issued a decision of Substantially Equivalent on November 1, 1996. The device falls under product code CCL (Analyzer, Gas, Oxygen, Gaseous-Phase), a Class II device regulated under 21 CFR 868.1720. Ametek, Inc. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 1, 1996
Date Received
May 2, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Analyzer, Gas, Oxygen, Gaseous-Phase
Device Class
Class II
Regulation Number
868.1720
Review Panel
AN
Submission Type