Cleared Traditional

WESTMED PEDIATRIC & ADULT MEDIUM CONCENTRATION OXYGEN MASK

K953464 · Westmed, Inc. · Anesthesiology
Sep 1995
Decision
56d
Days
Class 1
Risk

About This 510(k) Submission

K953464 is an FDA 510(k) clearance for the WESTMED PEDIATRIC & ADULT MEDIUM CONCENTRATION OXYGEN MASK, a Mask, Oxygen (Class I — General Controls, product code BYG), submitted by Westmed, Inc. (Tucson, US). The FDA issued a Cleared decision on September 18, 1995, 56 days after receiving the submission on July 24, 1995. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5580.

Submission Details

510(k) Number K953464 FDA.gov
FDA Decision Cleared SESE
Date Received July 24, 1995
Decision Date September 18, 1995
Days to Decision 56 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

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