Home / 510(k) Clearances / K051007

510(k) K051007

ACCU02 SYSTEM by Miti Corp. — Product Code NFB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 16, 2005
Date Received
April 20, 2005
Clearance Type
Traditional
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 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)