Cleared Traditional

OHMEDA - LOW FLOW FLOWMETER

K910316 · Ohmeda Medical · Anesthesiology
Apr 1991
Decision
78d
Days
Class 1
Risk

About This 510(k) Submission

K910316 is an FDA 510(k) clearance for the OHMEDA - LOW FLOW FLOWMETER, a Flowmeter, Tube, Thorpe, Back-pressure Compensated (Class I — General Controls, product code CAX), submitted by Ohmeda Medical (Columbia, US). The FDA issued a Cleared decision on April 12, 1991, 78 days after receiving the submission on January 24, 1991. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.2340.

Submission Details

510(k) Number K910316 FDA.gov
FDA Decision Cleared SESE
Date Received January 24, 1991
Decision Date April 12, 1991
Days to Decision 78 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