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510(k) K913501

TRACHEOSTOMY MASK by B & F Medical Products, Inc. — Product Code BYG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 13, 1992
Date Received
August 7, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Mask, Oxygen
Device Class
Class I
Regulation Number
868.5580
Review Panel
AN
Submission Type

Other clearances by B & F Medical Products, Inc.

  • K942645 — B&F MEDICAL OXYGEN REG MECICAL OXY COMPRESS GAS REG (July 27, 1994)
  • K920573 — CANNULA NASAL OXYGEN (August 11, 1992)
  • K861325 — MAXI-USE O2 DEVICE (September 9, 1986)
  • K861054 — DISPOSABLE RESCUE BREATHING DEVICE (April 9, 1986)
  • K853004 — PORTABLE OXYGEN UNIT (August 29, 1985)
  • K843691 — PORTABLE OXYGEN UNIT (November 7, 1984)
  • K823532 — STOCK #64091-PEDIATRIC OXYGEN MASK (January 5, 1983)
  • K811404 — TRAVELAIRE (June 9, 1981)
  • K802644 — EMERG. OXYGEN KIT #65350 & #65399 CASE (December 22, 1980)
  • K802646 — HAND PERCUSSOR CUP #65210 (November 12, 1980)

Other clearances for product code BYG

  • K963298 — FIRST AID KIT(S) (November 6, 1996)
  • K962848 — HANS RUDOLPH NASAL CPAP MASK (October 16, 1996)
  • K945482 — DISPOSABLE, CPAP OXYGEN MASK (September 19, 1995)
  • K953464 — WESTMED PEDIATRIC & ADULT MEDIUM CONCENTRATION OXYGEN MASK (September 18, 1995)
  • K953039 — VARIOUS ADULT & CHILD HIGH CON/NONREBREATH OXY MASKS (September 15, 1995)
  • K945472 — WESTMED PEDIATRIC AND ADULT AEROSOL MASK (February 7, 1995)
  • K942907 — JEMSDAL MASK (August 31, 1994)
  • K940888 — SYSTEM 22 PAEDIATRIC MASK (April 19, 1994)
  • K940887 — SYSTEM 22 ADULT MASK (April 19, 1994)
  • K931952 — MEDWAY OXYGEN MASK (August 20, 1993)