Home / 510(k) Clearances / K050153

510(k) K050153

SPIRIT, MODEL HAS by Caire, Inc. — Product Code BYJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 15, 2005
Date Received
January 24, 2005
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 Caire, Inc.

  • K250671 — FreeStyle Comfort (AS200 / FreeStyle Comfort) (July 11, 2025)
  • K120785 — OMNI 3 OXYGEN SYSTEM (October 25, 2012)
  • K121167 — CAIRE COMPANION 5 OXYGEN CONCENTRATOR (May 2, 2012)
  • K080023 — MODIFICATION TO: SPIRIT (June 16, 2008)
  • K013251 — SPIRIT 300 (December 18, 2001)
  • K952268 — MODEL DELTA, OM OXYGEN CONCENTRATOR (August 11, 1995)

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)
  • K050414 — PLIX (April 11, 2005)