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510(k) K772141

AEROSOL & OXYGEN MASKS by B & F Medical Products, Inc. — Product Code BYG

K772141 is an FDA 510(k) premarket notification submitted by B & F Medical Products, Inc. for the device "AEROSOL & OXYGEN MASKS". The FDA issued a decision of Substantially Equivalent on January 3, 1978. The device falls under product code BYG (Mask, Oxygen), a Class I device regulated under 21 CFR 868.5580. B & F Medical Products, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 3, 1978
Date Received
November 14, 1977
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)
  • K913501 — TRACHEOSTOMY MASK (January 13, 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)

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)

FDA data resources