FDA 510(k)

Vicks RapidRead Digital Thermometer

Número K: K180131 · 2018-08-14

RequerenteKaz USA, Inc., A Helen of Troy Company

Data da decisão2018-08-14

Código do produtoFLL

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

Vicks RapidRead Digital 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 2018-08-14 under 510(k) number K180131. 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 Vicks RapidRead Digital Thermometer?

Vicks RapidRead Digital Thermometer is a medical device that received FDA 510(k) clearance on 2018-08-14. The listed applicant is Kaz USA, Inc., A Helen of Troy Company. The 510(k) number is K180131.

When did Vicks RapidRead Digital Thermometer receive FDA 510(k) clearance?

Vicks RapidRead Digital Thermometer received FDA 510(k) clearance on 2018-08-14, under 510(k) number K180131.

Who is the listed applicant for Vicks RapidRead Digital 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 Vicks RapidRead Digital Thermometer?

The FDA product code for Vicks RapidRead Digital Thermometer is FLL.

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