Cleared Traditional

B&F MEDICAL OXYGEN REG MECICAL OXY COMPRESS GAS REG

K942645 · B & F Medical Products, Inc. · Anesthesiology

Jul 1994

Decision

54d

Days

Class 1

Risk

About This 510(k) Submission

K942645 is an FDA 510(k) clearance for the B&F MEDICAL OXYGEN REG MECICAL OXY COMPRESS GAS REG, a Gauge, Gas Pressure, Cylinder/pipeline (Class I — General Controls, product code BXH), submitted by B & F Medical Products, Inc. (Washington, US). The FDA issued a Cleared decision on July 27, 1994, 54 days after receiving the submission on June 3, 1994. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.2610.

Submission Details

510(k) Number	K942645 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 03, 1994
Decision Date	July 27, 1994
Days to Decision	54 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Statement