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510(k) K760680

INTERMITTENT MANDATORY VENTILATION by B & F Medical Products, Inc. — Product Code CBO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 27, 1976
Date Received
September 20, 1976
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Attachment, Intermittent Mandatory Ventilation (Imv)
Device Class
Class II
Regulation Number
868.5955
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 CBO

  • K811991 — SIMVAC (August 12, 1981)
  • K811908 — IMV MANIFOLDS (July 16, 1981)
  • K791912 — IMV FOR MONITORING #M-510 (October 9, 1979)
  • K791913 — IMV MANIFOLD #M-506 (October 9, 1979)
  • K791904 — IMV W/BAG & HOSES #M-509 (October 9, 1979)
  • K791906 — IMV W/BAG #M-507 (October 9, 1979)
  • K791905 — IMV W/BAG & TUBING #M-508 (October 9, 1979)
  • K791909 — IMV BUSHING #M-513 (October 9, 1979)
  • K791911 — FALL-SAFE IMV #M-511 (October 9, 1979)
  • K781706 — RESPIRATOR/GILL 1/SIMV (January 22, 1979)