Home / 510(k) Clearances / K013472

510(k) K013472

TOTAL O2 by Chad Therapeutics, Inc. — Product Code CAW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 28, 2001
Date Received
October 18, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Generator, Oxygen, Portable
Device Class
Class II
Regulation Number
868.5440
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)
  • K010389 — CHAD THERAPEUTICS OXYMATIC MODEL 401 AND OXYMATIC MODEL 411 (March 23, 2001)
  • K003455 — MODIFICATION TO CHAD THERAPEUTICS OXYMATIC MODEL 401 (December 6, 2000)
  • 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 CAW

  • K251534 — Oxygen Concentrator (J10A) (December 29, 2025)
  • K251764 — Oxygen Concentrator-P2-O5E (December 22, 2025)
  • K252616 — Portable oxygen concentrator (JLO-190P) (December 22, 2025)
  • K252268 — V series portable oxygen concentrator (V5, V5C, V6, V6C) (December 16, 2025)
  • K250805 — DeVilbiss PulmO2 10-Liter Oxygen Concentrator (1060AW) (December 9, 2025)
  • K251607 — Oxygen Concentrator (J5A) (November 21, 2025)
  • K243833 — Portable oxygen concentrator (JAY-1000P) (September 29, 2025)
  • K250625 — Portable oxygen concentrator (W-R1(MAX)); Portable oxygen concentrator (W-R1); (August 27, 2025)
  • K251130 — Portable Oxygen Concentrator (JM-P50A) (August 21, 2025)
  • K250671 — FreeStyle Comfort (AS200 / FreeStyle Comfort) (July 11, 2025)