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510(k) K832725

DUAL DIAL VENTURI STYLE MASK by Airlife, Inc. — Product Code BYF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 20, 1983
Date Received
August 12, 1983
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.

  • K834573 — AQUA TRAP (March 5, 1984)
  • K834570 — VOLUME VENTILATOR CIRCUIT W/WATER 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)
  • 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)
  • K821128 — DISPOSABLE THERMOPLASTIC RUBBER MOUTH (May 13, 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)
  • K812066 — PERCENTO MASK, PEDIATRIC, UNDER-THE-CHIN (August 3, 1981)
  • K810947 — AIR ENTRAINMENT TRACH T (June 2, 1981)
  • K810946 — ADULT & PEDIATRIC TRACHEOSTOMY MASKS (June 2, 1981)
  • K810373 — VENTURI MASK/DELIVERY SYSTEM #'S (March 17, 1981)