Cleared Traditional

OXYGEN REGULATORS #50 PRT & BGT(BGT15,BGT18

K852374 · The Timeter Group · Anesthesiology

Jul 1985

Decision

38d

Days

Class 1

Risk

About This 510(k) Submission

K852374 is an FDA 510(k) clearance for the OXYGEN REGULATORS #50 PRT & BGT(BGT15,BGT18, a Regulator, Pressure, Gas Cylinder (Class I — General Controls, product code CAN), submitted by The Timeter Group (Lancaster, US). The FDA issued a Cleared decision on July 12, 1985, 38 days after receiving the submission on June 4, 1985. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.2700.

Submission Details

510(k) Number	K852374 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 04, 1985
Decision Date	July 12, 1985
Days to Decision	38 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	—