Cleared Traditional

AIRCO 2000 SERIES FLOWMETERS

K862797 · Airco, Inc. · Anesthesiology
Aug 1986
Decision
17d
Days
Class 1
Risk

About This 510(k) Submission

K862797 is an FDA 510(k) clearance for the AIRCO 2000 SERIES FLOWMETERS, a Flowmeter, Tube, Thorpe, Back-pressure Compensated (Class I — General Controls, product code CAX), submitted by Airco, Inc. (Virginia Beach, US). The FDA issued a Cleared decision on August 8, 1986, 17 days after receiving the submission on July 22, 1986. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.2340.

Submission Details

510(k) Number K862797 FDA.gov
FDA Decision Cleared SESE
Date Received July 22, 1986
Decision Date August 08, 1986
Days to Decision 17 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