Cleared Traditional

K850106 - AIRCO NITROUS OXIDE REGULATOR
(FDA 510(k) Clearance)

K850106 · Airco, Inc. · Anesthesiology
Jan 1985
Decision
13d
Days
Class 1
Risk

K850106 is an FDA 510(k) clearance for the AIRCO NITROUS OXIDE REGULATOR, a Regulator, Pressure, Gas Cylinder (Class I — General Controls, product code CAN), submitted by Airco, Inc. (Virginia Beach, US). The FDA issued a Cleared decision on January 24, 1985, 13 days after receiving the submission on January 11, 1985. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.2700.

Submission Details

510(k) Number K850106 FDA.gov
FDA Decision Cleared SESE
Date Received January 11, 1985
Decision Date January 24, 1985
Days to Decision 13 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary

Device Classification

Product Code CAN — Regulator, Pressure, Gas Cylinder
Device Class Class I — General Controls
CFR Regulation 21 CFR 868.2700

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