Cleared Traditional

K950777 - OXYGEN REGULATOR
(FDA 510(k) Clearance)

K950777 · Mada Medical Products, Inc. · Anesthesiology

Apr 1995

Decision

52d

Days

Class 1

Risk

K950777 is an FDA 510(k) clearance for the OXYGEN REGULATOR, a Regulator, Pressure, Gas Cylinder (Class I — General Controls, product code CAN), submitted by Mada Medical Products, Inc. (Carlstadt, US). The FDA issued a Cleared decision on April 14, 1995, 52 days after receiving the submission on February 21, 1995. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.2700.

Submission Details

510(k) Number	K950777 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 21, 1995
Decision Date	April 14, 1995
Days to Decision	52 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Statement