Cleared Traditional

DISPOSABLE, ANESTHESIA/RESPIRATORY FACE MASK

K945440 · Fvtnks · Anesthesiology

Nov 1994

Decision

Days

Class 1

Risk

About This 510(k) Submission

K945440 is an FDA 510(k) clearance for the DISPOSABLE, ANESTHESIA/RESPIRATORY FACE MASK, a Mask, Gas, Anesthetic (Class I — General Controls, product code BSJ), submitted by Fvtnks (Indianapolis, US). The FDA issued a Cleared decision on November 8, 1994, 1 days after receiving the submission on November 7, 1994. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5550.

Submission Details

510(k) Number	K945440 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 07, 1994
Decision Date	November 08, 1994
Days to Decision	1 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Statement