510(k) K850626

CARNATION OXYGEN by Cathay Consolidated, Inc. — Product Code BYG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 12, 1985
Date Received
February 19, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Mask, Oxygen
Device Class
Class I
Regulation Number
868.5580
Review Panel
AN
Submission Type