Cleared Traditional

K852623 - OXY-ONE
(FDA 510(k) Clearance)

K852623 · Ashai Co. , Ltd. · Anesthesiology device

Sep 1985

Decision

90d

Days

Class 1

Risk

K852623 is an FDA 510(k) clearance for the OXY-ONE. This device is classified as 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 FDA review panel. Regulated under 21 CFR 868.5580.

Submission Details

510(k) Number	K852623 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	June 20, 1985
Decision Date	September 18, 1985
Days to Decision	90 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	—