K253479

Optiflow Switch+ Filtered Nasal Interface with CO2 Sampling (AA042J)

510(k) number: K253479
Device name: Optiflow Switch+ Filtered Nasal Interface with CO2 Sampling (AA042J)
Applicant: Fisher & Paykel Healthcare, Ltd. NZ
Product code: BTT — Humidifier, Respiratory Gas, (Direct Patient Interfa
Decision date: 2025-12-19
Date received: 2025-10-14
Decision: Substantially Equivalent
Clearance type: Special
Advisory committee: Anesthesiology

Also available from FDA: K253479.pdf

Official FDA record: K253479

Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.