Cleared Traditional

OXY-TWO

K852624 · Ashai Co. , Ltd. · Anesthesiology
Sep 1985
Decision
90d
Days
Class 1
Risk

About This 510(k) Submission

K852624 is an FDA 510(k) clearance for the OXY-TWO, a Mask, Oxygen (Class I — General Controls, product code BYG), submitted by Ashai Co. , Ltd. (Australia, AU). The FDA issued a Cleared decision on September 18, 1985, 90 days after receiving the submission on June 20, 1985. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5580.

Submission Details

510(k) Number K852624 FDA.gov
FDA Decision Cleared SESE
Date Received June 20, 1985
Decision Date September 18, 1985
Days to Decision 90 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary —

Device Classification

Product Code BYG — Mask, Oxygen
Device Class Class I — General Controls
CFR Regulation 21 CFR 868.5580