Cleared Traditional

CARNATION - OXYGEN MASK

K851466 · Dadsun Corp., Ltd. · Anesthesiology
Jun 1985
Decision
69d
Days
Class 1
Risk

About This 510(k) Submission

K851466 is an FDA 510(k) clearance for the CARNATION - OXYGEN MASK, a Mask, Oxygen (Class I — General Controls, product code BYG), submitted by Dadsun Corp., Ltd. (Taipei, TW). The FDA issued a Cleared decision on June 19, 1985, 69 days after receiving the submission on April 11, 1985. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5580.

Submission Details

510(k) Number K851466 FDA.gov
FDA Decision Cleared SESE
Date Received April 11, 1985
Decision Date June 19, 1985
Days to Decision 69 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