Cleared Traditional

ADULT & PEDIATRIC TRACHEOSTOMY MASKS

K810946 · Airlife, Inc. · Anesthesiology
Jun 1981
Decision
56d
Days
Class 1
Risk

About This 510(k) Submission

K810946 is an FDA 510(k) clearance for the ADULT & PEDIATRIC TRACHEOSTOMY MASKS, a Mask, Oxygen, Low Concentration, Venturi (Class I — General Controls, product code BYF), submitted by Airlife, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 2, 1981, 56 days after receiving the submission on April 7, 1981. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5600.

Submission Details

510(k) Number K810946 FDA.gov
FDA Decision Cleared SESE
Date Received April 07, 1981
Decision Date June 02, 1981
Days to Decision 56 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary —

Device Classification

Product Code BYF — Mask, Oxygen, Low Concentration, Venturi
Device Class Class I — General Controls
CFR Regulation 21 CFR 868.5600

Similar Devices — BYF Mask, Oxygen, Low Concentration, Venturi

All 18
TRACH MASK MODEL (245, 246)
K955483 · Hospitak, Inc. · Feb 1996
VENTIMASK MK IV
K951652 · Flexicare Medical, Ltd. · Apr 1995
CARNATION TRACHEOSTOMY MASKS
K894457 · Dadsun Corp., Ltd. · Oct 1989
VENTURI MASK/ADULT & PAEDIATRIC
K860873 · Dhd Medical Products Div. Diemolding Corp. · Mar 1986
VENTURI MASK W/HUMDIFICATION CUP ADULT/PAEDIATRIC
K860874 · Dhd Medical Products Div. Diemolding Corp. · Mar 1986
OXY-DIAL
K852618 · Ashai Co. , Ltd. · Sep 1985