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510(k) K832143

MARK III OXYGEN WALKER SYS. RESERVOIR by Linde Div. Union Carbide Corp. — Product Code BYJ

K832143 is an FDA 510(k) premarket notification submitted by Linde Div. Union Carbide Corp. for the device "MARK III OXYGEN WALKER SYS. RESERVOIR". The FDA issued a decision of Substantially Equivalent on August 26, 1983. The device falls under product code BYJ (Unit, Liquid-Oxygen, Portable), a Class II device regulated under 21 CFR 868.5655. Linde Div. Union Carbide Corp. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 26, 1983
Date Received
July 5, 1983
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 Linde Div. Union Carbide Corp.

  • K882208 — MEDIBLEND (TM) MEDICAL LASER GAS MIXTURES (August 3, 1988)
  • K882209 — MEDIBLEND (TM) CLINICAL BLOOD GAS MIXTURES (August 2, 1988)
  • K882210 — MEDIBLEND (TM) LUNG DIFFUSION GAS MIXTURES (June 21, 1988)
  • K823582 — OXYGEN CONCENTRATOR UCC-100 (January 5, 1983)
  • K821841 — MEDIGAS SUCTION/DRAINAGE EQUIPMENT (July 2, 1982)

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