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510(k) K810946

ADULT & PEDIATRIC TRACHEOSTOMY MASKS by Airlife, Inc. — Product Code BYF

K810946 is an FDA 510(k) premarket notification submitted by Airlife, Inc. for the device "ADULT & PEDIATRIC TRACHEOSTOMY MASKS". The FDA issued a decision of Substantially Equivalent on June 2, 1981. The device falls under product code BYF (Mask, Oxygen, Low Concentration, Venturi), a Class I device regulated under 21 CFR 868.5600. Airlife, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 2, 1981
Date Received
April 7, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Mask, Oxygen, Low Concentration, Venturi
Device Class
Class I
Regulation Number
868.5600
Review Panel
AN
Submission Type

Other clearances by Airlife, Inc.

  • K834570 — VOLUME VENTILATOR CIRCUIT W/WATER TRAP (March 5, 1984)
  • K834573 — AQUA TRAP (March 5, 1984)
  • K834077 — SINGLE USE NEBULIZER-ADJUST-AIR ENTRAIN (December 12, 1983)
  • K833196 — VOLUME VENTILATOR CIRCUIT-NEBULIZER (November 3, 1983)
  • K833197 — TRACH SWIVE/CONNECTOR (October 28, 1983)
  • K832725 — DUAL DIAL VENTURI STYLE MASK (September 20, 1983)
  • K831246 — WHISTLER IN-LINE PRESSURE RELEASE VALVE (July 26, 1983)
  • K830895 — SINGLE USE NEBULIZER, ADJUST. AIR- (April 28, 1983)
  • K830896 — HUMIDIFIER, WITH OR WITHOUT ADAPTER (April 18, 1983)
  • K821129 — AIRLIFE NEBULIZER HEATER (May 18, 1982)

Other clearances for product code BYF

  • K955483 — TRACH MASK MODEL (245, 246) (February 28, 1996)
  • K951652 — VENTIMASK MK IV (April 27, 1995)
  • K894457 — CARNATION TRACHEOSTOMY MASKS (October 13, 1989)
  • K860873 — VENTURI MASK/ADULT & PAEDIATRIC (March 20, 1986)
  • K860874 — VENTURI MASK W/HUMDIFICATION CUP ADULT/PAEDIATRIC (March 19, 1986)
  • K852618 — OXY-DIAL (September 18, 1985)
  • K832725 — DUAL DIAL VENTURI STYLE MASK (September 20, 1983)
  • K812066 — PERCENTO MASK, PEDIATRIC, UNDER-THE-CHIN (August 3, 1981)
  • K810947 — AIR ENTRAINMENT TRACH T (June 2, 1981)
  • K810373 — VENTURI MASK/DELIVERY SYSTEM #'S (March 17, 1981)

FDA data resources