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510(k) K942645

B&F MEDICAL OXYGEN REG MECICAL OXY COMPRESS GAS REG by B & F Medical Products, Inc. — Product Code BXH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 27, 1994
Date Received
June 3, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Gauge, Gas Pressure, Cylinder/Pipeline
Device Class
Class I
Regulation Number
868.2610
Review Panel
AN
Submission Type

Other clearances by B & F Medical Products, Inc.

  • 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)
  • K802646 — HAND PERCUSSOR CUP #65210 (November 12, 1980)

Other clearances for product code BXH

  • K853040 — PRESSURE GAUGE (October 10, 1985)
  • K843212 — LOW PRESSURE ALARM FOR OXYGEN CYLINDER (September 19, 1984)
  • K770614 — MONITOR, GAS MANIFOLD (April 7, 1977)