510(k) K861199

BUNN MODEL 22 OXYGEN FLOW CONTROLLER by The John Bunn Co. — Product Code NFB

K861199 is an FDA 510(k) premarket notification submitted by The John Bunn Co. for the device "BUNN MODEL 22 OXYGEN FLOW CONTROLLER". The FDA issued a decision of Substantially Equivalent on August 26, 1986. The device falls under product code NFB (Conserver, Oxygen), a Class II device regulated under 21 CFR 868.5905. The John Bunn Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 26, 1986
Date Received
March 31, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Conserver, Oxygen
Device Class
Class II
Regulation Number
868.5905
Review Panel
AN
Submission Type