F&P Optiflow Air/Oxygen Flow Source— 510(k) K243917

Substantially Equivalent

Fisher & Paykel Healthcare, Ltd.

FDA 510(k) clearance K243917 for F&P Optiflow Air/Oxygen Flow Source, Substantially Equivalent on 2025-07-14. Applicant: Fisher & Paykel Healthcare, Ltd..

Clearance details

Applicant: Fisher & Paykel Healthcare, Ltd.
Product code: Code BZR
Advisory panel: Anesthesiology
Date received: 2024-12-20
Decision date: 2025-07-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Auckland, NZ

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