Cleared Traditional

AIR-SOFT-DISPOSABLE, ANESTHESISA/RESPIRATORY FACE MASK

K951043 · Promedic, Inc. · Anesthesiology

Jun 1995

Decision

92d

Days

Class 1

Risk

About This 510(k) Submission

K951043 is an FDA 510(k) clearance for the AIR-SOFT-DISPOSABLE, ANESTHESISA/RESPIRATORY FACE MASK, a Mask, Gas, Anesthetic (Class I — General Controls, product code BSJ), submitted by Promedic, Inc. (Indianapolis, US). The FDA issued a Cleared decision on June 7, 1995, 92 days after receiving the submission on March 7, 1995. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5550.

Submission Details

510(k) Number	K951043 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 07, 1995
Decision Date	June 07, 1995
Days to Decision	92 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Statement