510(k) K782062

ANALYZER, OXYGEN MODEL M25RA & M25RAD by Catalyst Research Corp. — Product Code CCL

K782062 is an FDA 510(k) premarket notification submitted by Catalyst Research Corp. for the device "ANALYZER, OXYGEN MODEL M25RA & M25RAD". The FDA issued a decision of Substantially Equivalent on February 15, 1979. The device falls under product code CCL (Analyzer, Gas, Oxygen, Gaseous-Phase), a Class II device regulated under 21 CFR 868.1720. Catalyst Research Corp. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 15, 1979
Date Received
December 7, 1978
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