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510(k) K250322

Respond OC Conserving Regulator (130-0800) by Responsive Respiratory — Product Code NFB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 24, 2025
Date Received
February 4, 2025
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 by Responsive Respiratory

  • K061785 — CYL-FIL OXYGEN SYSTEM (September 7, 2006)

Other clearances for product code NFB

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  • 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)
  • K060751 — INOVO, INC. ACCUPULSE SINGLE LUMEN CONSERVING REGULATOR (July 18, 2006)