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510(k) K780626

VENTURI OXYGEN MASK by Hospitak, Inc. — Product Code BYF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 26, 1978
Date Received
April 14, 1978
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 Hospitak, Inc.

  • K955483 — TRACH MASK MODEL (245, 246) (February 28, 1996)
  • K954787 — ILLUMINATOR (January 31, 1996)
  • K953620 — WARM N WET HMEF W/LUER ADAPTER (August 25, 1995)
  • K953619 — WARM N WET HME W/LUER ADAPTER (August 25, 1995)
  • K915750 — DISPOSABLE BACTERIAL BREATHNG FILTER (November 30, 1994)
  • K920842 — AEROSOL DELIVERY SYSTEMS (May 15, 1992)
  • K915228 — DISPOSABLE CO2 GAS SAMPLING/OXYGEN DELIVERY CANNUL (February 11, 1992)
  • K873286 — DISPOSABLE, MANUAL PULMONARY RESUSCITATOR (October 26, 1987)
  • K853600 — INFLATABLE AIR SPLINTS (September 19, 1985)
  • K844328 — OXYGEN CONCENTRATOR (December 4, 1984)

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)
  • K810946 — ADULT & PEDIATRIC TRACHEOSTOMY MASKS (June 2, 1981)