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510(k) K003455

MODIFICATION TO CHAD THERAPEUTICS OXYMATIC MODEL 401 by Chad Therapeutics, Inc. — Product Code NFB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 6, 2000
Date Received
November 7, 2000
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Conserver, Oxygen
Device Class
Class II
Regulation Number
868.5905
Review Panel
AN
Submission Type

Other clearances by Chad Therapeutics, Inc.

  • K081176 — FLOCHANNEL (July 28, 2008)
  • K070740 — CHAD THERAPEUTICS BONSAI MODEL 800 (May 7, 2007)
  • K042142 — CHAD THERAPEUTICS LOTUS, MODELS OM-700 AND OM-700S (September 20, 2004)
  • K033364 — CHAD THERAPEUTICS SAGE (May 11, 2004)
  • K020475 — CHAD THERAPEUTICS OXYPENUMATIC CYPRESS MODEL 511 (July 5, 2002)
  • K013472 — TOTAL O2 (November 28, 2001)
  • K010389 — CHAD THERAPEUTICS OXYMATIC MODEL 401 AND OXYMATIC MODEL 411 (March 23, 2001)
  • K000890 — CHAD THERAPEUTICS OXYMATIC MODEL 401 (June 16, 2000)
  • K971889 — CHAD TOTAL O2 DELIVERY SYSTEM (November 17, 1997)
  • K884562 — OXYMATIC-24 (January 9, 1989)

Other clearances for product code NFB

  • K250322 — Respond OC Conserving Regulator (130-0800) (July 24, 2025)
  • K220591 — Proxima (December 15, 2022)
  • K221014 — Effortless Oxygen Conserver System Models Effortless Pro and Effortless Mobile (October 17, 2022)
  • K200401 — Apogee (November 14, 2020)
  • K151506 — Demand Nasal Oxygen Cannula, Modified Demand Nasal Oxygen Cannula (March 11, 2016)
  • K131023 — THERAFLOW SINGLE LUMEN AND THERAFLOW DUAL LUMEN (October 11, 2013)
  • K113111 — CHAD THERAPEUTIC EVOLUTION ELECTRONIC OXYGEN CONSERVER WITH MOTION (December 8, 2011)
  • K103392 — CHAD THERAPEUTIC EVOLUTION ELECTRONIC OXYGEN CONSERVER (December 17, 2010)
  • K090421 — MODEL 350G GAS CONSERVER (May 29, 2009)
  • K070740 — CHAD THERAPEUTICS BONSAI MODEL 800 (May 7, 2007)