Cleared Traditional

CLASSIC (TM) 200 OXYGEN FLOWMETER

K871452 · The Timeter Group · Anesthesiology
Jun 1987
Decision
70d
Days
Class 1
Risk

About This 510(k) Submission

K871452 is an FDA 510(k) clearance for the CLASSIC (TM) 200 OXYGEN FLOWMETER, a Flowmeter, Tube, Thorpe, Back-pressure Compensated (Class I — General Controls, product code CAX), submitted by The Timeter Group (Lancaster, US). The FDA issued a Cleared decision on June 22, 1987, 70 days after receiving the submission on April 13, 1987. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.2340.

Submission Details

510(k) Number K871452 FDA.gov
FDA Decision Cleared SESE
Date Received April 13, 1987
Decision Date June 22, 1987
Days to Decision 70 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary —

Device Classification

Product Code CAX — Flowmeter, Tube, Thorpe, Back-pressure Compensated
Device Class Class I — General Controls
CFR Regulation 21 CFR 868.2340