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510(k) K234053

F&P Optiflow Flow Diverter by Fisher &Paykel Healthcare , Ltd. — Product Code CBP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 9, 2024
Date Received
December 22, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Valve, Non-Rebreathing
Device Class
Class II
Regulation Number
868.5870
Review Panel
AN
Submission Type

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  • K231956 — F&P Optiflow+ Duet Nasal Cannula (February 7, 2024)
  • K223684 — F&P 820 Humidification System (September 5, 2023)

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  • K173770 — OJR215 Pressure Relief Manifold (April 5, 2019)
  • K171961 — Compower CPR Mask With Oxygen Port, Compower CPR Mask Without Oxygen Port, Compo (November 17, 2017)
  • K152521 — Seal Rite Non-Rebreathing Valve (June 3, 2016)
  • K142764 — KYOLING CPR Mask with Oxygen Port and Without Oxygen Port (July 9, 2015)
  • K142402 — BigEasy Non-Rebreathing Valve (March 23, 2015)
  • K132143 — EXHALATION VALVE (June 4, 2014)
  • K112126 — GENUINE FIRST AID CPR MASK (December 1, 2011)