Cleared Traditional

WESTMED PEDIATRIC AND ADULT AEROSOL MASK

K945472 · Westmed Intl. · Anesthesiology

Feb 1995

Decision

91d

Days

Class 1

Risk

About This 510(k) Submission

K945472 is an FDA 510(k) clearance for the WESTMED PEDIATRIC AND ADULT AEROSOL MASK, a Mask, Oxygen (Class I — General Controls, product code BYG), submitted by Westmed Intl. (Tucson, US). The FDA issued a Cleared decision on February 7, 1995, 91 days after receiving the submission on November 8, 1994. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5580.

Submission Details

510(k) Number	K945472 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 08, 1994
Decision Date	February 07, 1995
Days to Decision	91 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Summary PDF