510(k) K854799

EMERSON MODEL 3MV-OAA ALARM MODULE by J. H. Emerson Co. — Product Code CCL

K854799 is an FDA 510(k) premarket notification submitted by J. H. Emerson Co. for the device "EMERSON MODEL 3MV-OAA ALARM MODULE". The FDA issued a decision of Substantially Equivalent on December 11, 1985. The device falls under product code CCL (Analyzer, Gas, Oxygen, Gaseous-Phase), a Class II device regulated under 21 CFR 868.1720. J. H. Emerson Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 11, 1985
Date Received
December 2, 1985
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