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510(k) K200401

Apogee by Incoba Ltd D/B/A Dynaris — Product Code NFB

K200401 is an FDA 510(k) premarket notification submitted by Incoba Ltd D/B/A Dynaris for the device "Apogee". The FDA issued a decision of Substantially Equivalent on November 14, 2020. The device falls under product code NFB (Conserver, Oxygen), a Class II device regulated under 21 CFR 868.5905.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 14, 2020
Date Received
February 18, 2020
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)
  • 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)
  • K060751 — INOVO, INC. ACCUPULSE SINGLE LUMEN CONSERVING REGULATOR (July 18, 2006)

FDA data resources