510(k) K872001

MODEL TPC-1A OXYGEN ANALYZER by Medical, Inc. — Product Code CCL

K872001 is an FDA 510(k) premarket notification submitted by Medical, Inc. for the device "MODEL TPC-1A OXYGEN ANALYZER". The FDA issued a decision of Substantially Equivalent on June 15, 1987. The device falls under product code CCL (Analyzer, Gas, Oxygen, Gaseous-Phase), a Class II device regulated under 21 CFR 868.1720. Medical, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 15, 1987
Date Received
May 26, 1987
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