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510(k) K234058

Device
F&P Optiflow Filtered Nasal Interface with Anesthesia Mask Compatibility (AA041J)
Applicant
Fisher & Paykel Healthcare, Ltd.
510(k) number
K234058
Product code
BTT
Decision
Substantially Equivalent (SESE)
Decision date
2024-08-08
Date received
2023-12-22
Regulation
868.5450
Classification name
Humidifier, Respiratory Gas, (Direct Patient Interface)
Medical specialty
Anesthesiology
Review panel
Anesthesiology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Reena Daken
Address
15 Maurice Paykel Pl., E. Tamaki Auckland NZ 2013 2013

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code BTT#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K254078HVT 2.0Vapotherm, Inc.2026-04-13
K251448FL-10000U Respiratory HumidifierFlexicare Medical Limited.2026-01-16
K251419Laboratorios Biogalenic Sterile Water for Inhalation, USPLaboratorios Biogalenic S.A. DE C.V.2026-01-14
K253479Optiflow Switch+ Filtered Nasal Interface with CO2 Sampling (AA042J)Fisher & Paykel Healthcare, Ltd.2025-12-19
K250312Hudson RCI® Comfort Flo Nasal Cannula Premature, Infant; Hudson RCI® Comfort Flo Plus and Soft Plus Cannula Extra SmallMedline Industries, LP2025-07-02
K251611Optiflow+ Nasal Cannula - Small (OPT942); Optiflow+ Nasal Cannula - Medium (OPT944); Optiflow+ Nasal Cannula - Large (OPT946); Optiflow+ Nasal Cannula Small (MYOPT9SMALL); Optiflow+ Nasal Cannula Medium (MYOPT9MEDIUM); Optiflow+ Nasal Cannula Large (MYOPT9LARGE)Fisher & Paykel Healthcare, Ltd.2025-06-25
K242717Laboratorios Biogalenic Sterile Water for Inhalation, USPLaboratorios Biogalenic S.A. DE C.V.2025-01-30
K241778Hudson RCI Comfort Flo® CubCannula™Medline Industries, LP2024-12-19
K240163Hudson RCI® Comfort Flo Nasal Cannula; Hudson RCI® Comfort Flo Plus CannulaMedline Industries, LP2024-09-27
K233707HFT150Invent Medical Corporation2024-06-14
K233821F&P Optiflow Oxygen Kit (AA451J)Fisher & Paykel Healthcare, Ltd.2024-06-13
K222292F&P myAirvo 3Fisher & Paykel Healthcare2024-05-08
K231956F&P Optiflow+ Duet Nasal CannulaFisher & Paykel Healthcare, Ltd.2024-02-07
K230559Hudson RCI® Disposable Humidifier with 4 PSI Pressure Relief Valve (3230), Hudson RCI® Disposable Humidifier with 6 PSI Pressure Relief Valve (3260)Medline Industries, Inc.2023-10-26
K223863BONHAWA Respiratory HumidifierTelesair, Inc.2023-10-13