Cleared Traditional

VARIOUS ADULT & CHILD HIGH CON/NONREBREATH OXY MASKS

K953039 · Dadsun Corp., Ltd. · Anesthesiology
Sep 1995
Decision
94d
Days
Class 1
Risk

About This 510(k) Submission

K953039 is an FDA 510(k) clearance for the VARIOUS ADULT & CHILD HIGH CON/NONREBREATH OXY MASKS, a Mask, Oxygen (Class I — General Controls, product code BYG), submitted by Dadsun Corp., Ltd. (Taipei, TW). The FDA issued a Cleared decision on September 15, 1995, 94 days after receiving the submission on June 13, 1995. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5580.

Submission Details

510(k) Number K953039 FDA.gov
FDA Decision Cleared SESE
Date Received June 13, 1995
Decision Date September 15, 1995
Days to Decision 94 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement

Device Classification

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