510(k) K812040

OXYGEN MONITOR 140/141 by Medix Medical Electronics (U.S.A.), Inc. — Product Code CCL

K812040 is an FDA 510(k) premarket notification submitted by Medix Medical Electronics (U.S.A.), Inc. for the device "OXYGEN MONITOR 140/141". The FDA issued a decision of Substantially Equivalent on September 21, 1981. The device falls under product code CCL (Analyzer, Gas, Oxygen, Gaseous-Phase), a Class II device regulated under 21 CFR 868.1720. Medix Medical Electronics (U.S.A.), Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 21, 1981
Date Received
July 21, 1981
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