F&P Optiflow Air/Oxygen Flow Source— 510(k) K243917
Substantially EquivalentFisher & 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.. Device class: 2.
Clearance details
- Applicant
- Fisher & Paykel Healthcare, Ltd.
- Product code
- Code BZR
- Device class
- Class 2
- Regulation
- 21 CFR 868.5330
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Auckland, NZ
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Data sourced from openFDA. This site is unofficial and independent of the FDA.