510(k) K942645

B&F MEDICAL OXYGEN REG MECICAL OXY COMPRESS GAS REG by B & F Medical Products, Inc. — Product Code BXH

K942645 is an FDA 510(k) premarket notification submitted by B & F Medical Products, Inc. for the device "B&F MEDICAL OXYGEN REG MECICAL OXY COMPRESS GAS REG". The FDA issued a decision of Substantially Equivalent on July 27, 1994. The device falls under product code BXH (Gauge, Gas Pressure, Cylinder/Pipeline), a Class I device regulated under 21 CFR 868.2610. B & F Medical Products, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 27, 1994
Date Received
June 3, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Gauge, Gas Pressure, Cylinder/Pipeline
Device Class
Class I
Regulation Number
868.2610
Review Panel
AN
Submission Type