Cleared Traditional

F&P Optiflow Flow Diverter

K234053 · Fisher &Paykel Healthcare , Ltd. · Anesthesiology
Aug 2024
Decision
231d
Days
Class 2
Risk

About This 510(k) Submission

K234053 is an FDA 510(k) clearance for the F&P Optiflow Flow Diverter, a Valve, Non-rebreathing (Class II — Special Controls, product code CBP), submitted by Fisher &Paykel Healthcare , Ltd. (Auckland, NZ). The FDA issued a Cleared decision on August 9, 2024, 231 days after receiving the submission on December 22, 2023. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5870.

Submission Details

510(k) Number K234053 FDA.gov
FDA Decision Cleared SESE
Date Received December 22, 2023
Decision Date August 09, 2024
Days to Decision 231 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code CBP — Valve, Non-rebreathing
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5870

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