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510(k) K840534

LIQUID OXYGEN SYSTEM by The John Bunn Co. — Product Code BYJ

K840534 is an FDA 510(k) premarket notification submitted by The John Bunn Co. for the device "LIQUID OXYGEN SYSTEM". The FDA issued a decision of Substantially Equivalent on March 2, 1984. The device falls under product code BYJ (Unit, Liquid-Oxygen, Portable), a Class II device regulated under 21 CFR 868.5655. The John Bunn Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 2, 1984
Date Received
February 8, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Unit, Liquid-Oxygen, Portable
Device Class
Class II
Regulation Number
868.5655
Review Panel
AN
Submission Type

Other clearances by The John Bunn Co.

  • K900854 — JOHN BUNN: MEDIX COMPACT TRAVELLER (April 23, 1990)
  • K883216 — BUNN MODEL 50 OXYGEN FLOW CONTROLLER (August 18, 1988)
  • K873071 — BUNN CONCENTRATOR MODEL 2100 SERIES (September 15, 1987)
  • K870094 — BUNN MODEL 530 ASPIRATOR (March 6, 1987)
  • K861435 — BUNN CONCENTRATOR MODEL 2011 WITH DEMAND VALVE (November 7, 1986)
  • K861199 — BUNN MODEL 22 OXYGEN FLOW CONTROLLER (August 26, 1986)
  • K862628 — BUNN MODEL 510 MEDICATION COMPRESSOR (August 7, 1986)
  • K855208 — BUNN LITE OXYGEN CONCENTRATOR (February 21, 1986)
  • K860060 — RX02 PLUS OXYGEN CONCENTRATOR (February 5, 1986)
  • K843811 — BUNN 3001 OXYGEN CONCENTRATOR (October 4, 1984)

Other clearances for product code BYJ

  • K130068 — DISMOUNTED MEDICAL & SUPPLEMENTAL OXYGEN SYSTEM (DMOS) (July 19, 2013)
  • K113767 — MOUNTED MEDICAL OXYGEN SYSTEM (June 29, 2012)
  • K103324 — PRECISION LIQUID OXYGEN SYSTEM (April 21, 2011)
  • K101272 — MASS OXYGEN DISTRIBUTION SYSTEM (MODS) MODEL 10C-0061-3 (August 20, 2010)
  • K081779 — GOLOX-93 (September 19, 2008)
  • K080023 — MODIFICATION TO: SPIRIT (June 16, 2008)
  • K072723 — RESPIRONICS GOLOX (March 20, 2008)
  • K072011 — COPD LIQUID OXYGEN PORTABLE, MODEL 300P (October 18, 2007)
  • K071581 — BACKPACK MEDICAL OXYGEN SYSTEM (July 11, 2007)
  • K050153 — SPIRIT, MODEL HAS (April 15, 2005)

FDA data resources