FDA 510(k)

inspired™ VHB20 Heated Humidifier

Número K: K222351 · 2022-12-21

RequerenteVincent Healthcare Products Limited

Data da decisão2022-12-21

Código do produtoBTT

Comité consultivoAN

DecisãoSubstantially Equivalent

Resumo do dispositivo

inspired™ VHB20 Heated Humidifier is the device name listed in this FDA 510(k) record. The listed applicant is Vincent Healthcare Products Limited. It received FDA 510(k) clearance on 2022-12-21 under 510(k) number K222351. The device is classified under product code BTT. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the inspired™ VHB20 Heated Humidifier?

inspired™ VHB20 Heated Humidifier is a medical device that received FDA 510(k) clearance on 2022-12-21. The listed applicant is Vincent Healthcare Products Limited. The 510(k) number is K222351.

When did inspired™ VHB20 Heated Humidifier receive FDA 510(k) clearance?

inspired™ VHB20 Heated Humidifier received FDA 510(k) clearance on 2022-12-21, under 510(k) number K222351.

Who is the listed applicant for inspired™ VHB20 Heated Humidifier?

The FDA 510(k) record lists Vincent Healthcare Products Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for inspired™ VHB20 Heated Humidifier?

The FDA product code for inspired™ VHB20 Heated Humidifier is BTT.

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Outros registros que listam Vincent Healthcare Products Limited como candidato(a)

K252066inspired™ Heated Breathing Circuit (510-008); inspired™ Heated Breathing Circuit (510-009); inspired™ Auto-feed Humidification Chamber (VHC10); inspired™ Auto-feed Humidification Chamber (VHC20)

Dispositivos Relacionados (Código: BTT)

K262268Optiflow Oxygen Kit (AA484J)Fisher and Paykel Healthcare Limited K254078HVT 2.0Vapotherm, Inc.K251448FL-10000U Respiratory HumidifierFlexicare Medical Limited.K251419Laboratorios Biogalenic Sterile Water for Inhalation, USPLaboratorios Biogalenic S.A. DE C.V.K253479Optiflow Switch+ Filtered Nasal Interface with CO2 Sampling (AA042J)Fisher & Paykel Healthcare, Ltd.K250312Hudson RCI® Comfort Flo Nasal Cannula Premature, Infant; Hudson RCI® Comfort Flo Plus and Soft Plus Cannula Extra SmallMedline Industries, LP

Fonte oficial

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