FDA 510(k)

Braun No Touch + Forehead NTF3000 Thermometer

Número K: K163516 · 2017-04-21

RequerenteKaz USA, Inc., A Helen of Troy Company

Data da decisão2017-04-21

Código do produtoFLL

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

Braun No Touch + Forehead NTF3000 Thermometer is the device name listed in this FDA 510(k) record. The listed applicant is Kaz USA, Inc., A Helen of Troy Company. It received FDA 510(k) clearance on 2017-04-21 under 510(k) number K163516. The device is classified under product code FLL. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Braun No Touch + Forehead NTF3000 Thermometer?

Braun No Touch + Forehead NTF3000 Thermometer is a medical device that received FDA 510(k) clearance on 2017-04-21. The listed applicant is Kaz USA, Inc., A Helen of Troy Company. The 510(k) number is K163516.

When did Braun No Touch + Forehead NTF3000 Thermometer receive FDA 510(k) clearance?

Braun No Touch + Forehead NTF3000 Thermometer received FDA 510(k) clearance on 2017-04-21, under 510(k) number K163516.

Who is the listed applicant for Braun No Touch + Forehead NTF3000 Thermometer?

The FDA 510(k) record lists Kaz USA, Inc., A Helen of Troy Company as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Braun No Touch + Forehead NTF3000 Thermometer?

The FDA product code for Braun No Touch + Forehead NTF3000 Thermometer is FLL.

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Dispositivos Relacionados (Código: FLL)

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Fonte oficial

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