510(k) K802644

EMERG. OXYGEN KIT #65350 & #65399 CASE by B & F Medical Products, Inc. — Product Code CAN

K802644 is an FDA 510(k) premarket notification submitted by B & F Medical Products, Inc. for the device "EMERG. OXYGEN KIT #65350 & #65399 CASE". The FDA issued a decision of Substantially Equivalent on December 22, 1980. The device falls under product code CAN (Regulator, Pressure, Gas Cylinder), a Class I device regulated under 21 CFR 868.2700. B & F Medical Products, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 22, 1980
Date Received
October 24, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Regulator, Pressure, Gas Cylinder
Device Class
Class I
Regulation Number
868.2700
Review Panel
AN
Submission Type