Cleared Traditional

ANESTHESIA FACE MASK

K953295 · Mallinckrodt Medical · Anesthesiology
Aug 1995
Decision
28d
Days
Class 1
Risk

About This 510(k) Submission

K953295 is an FDA 510(k) clearance for the ANESTHESIA FACE MASK, a Mask, Gas, Anesthetic (Class I — General Controls, product code BSJ), submitted by Mallinckrodt Medical (St Louis, US). The FDA issued a Cleared decision on August 11, 1995, 28 days after receiving the submission on July 14, 1995. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5550.

Submission Details

510(k) Number K953295 FDA.gov
FDA Decision Cleared SESE
Date Received July 14, 1995
Decision Date August 11, 1995
Days to Decision 28 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement

Device Classification

Product Code BSJ — Mask, Gas, Anesthetic
Device Class Class I — General Controls
CFR Regulation 21 CFR 868.5550

Similar Devices — BSJ Mask, Gas, Anesthetic

All 50
SuperNO2VA Device
K163277 · Revolutionary Medical Devices, Inc. · Oct 2017
ANESTHESIA/RESPIRATORY FACE MASK
K953107 · Medical Marketing Concepts · Aug 1995
BRIGAM MEDICAL DISPOSABLE ANESTHESIA/RESPIRATORY FACE MASK
K952689 · Owens-Brigam Medical Co. · Jul 1995
AIR-SOFT-DISPOSABLE, ANESTHESISA/RESPIRATORY FACE MASK
K951043 · Promedic, Inc. · Jun 1995
DISPOSABLE ADHESIVE FACE MASK
K950771 · Advanced Warming Systems, Inc. · Mar 1995
MASK, GAS, ANESTHETIC
K945894 · Hans Rudolph, Inc. · Jan 1995

More from Mallinckrodt Medical

View all
SEALGUARD EVAC ENDOTRACHEAL AND ENDOTRACHEAL TUBES
K082520 · BTR · Oct 2008
SHILEY TRACHEOSOFT XLT EXTENDED LENGTH TRACHEOSTOMY TUBE AND INNER CANNULA
K051416 · JOH · Jun 2005
HI-CARE CLOSED SUCTION SYSTEM
K972258 · BSY · Dec 1997
SHILEY EXTENDED LENGTH, DISPOSABLE CANNULA, TRACHEOSTOMY TUBE: CUFFED, DISTAL EXTENSION, CUFFED, PROXIMAL EXTENSION, CUF
K971267 · JOH · Sep 1997
PERCUTANEOUS DUAL CANNULA TRACHEOSTOMY TUBE WITH LOW PRESSURE/LOW PROFILE CUFF AND DISPOSABLE INNER CANNULA
K963732 · JOH · Jun 1997