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510(k) K780558

BOTTLE BREATHING DEVICE by B & F Medical Products, Inc. — Product Code BYO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 26, 1978
Date Received
April 5, 1978
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bottle, Blow
Device Class
Class I
Regulation Number
868.5220
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 BYO

  • K924541 — EPIDURAL MINIPACK (July 9, 1993)
  • K913527 — HYPERFREE (January 21, 1992)
  • K780407 — 2C7125 BLOW BOTTLE (April 10, 1978)