FDA 510(k)

Digital Thermometer

Número K: K161211 · 2016-08-29

RequerenteBiocare Asia Corporation , Ltd.

Data da decisão2016-08-29

Código do produtoFLL

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

Digital Thermometer is the device name listed in this FDA 510(k) record. The listed applicant is Biocare Asia Corporation , Ltd.. It received FDA 510(k) clearance on 2016-08-29 under 510(k) number K161211. 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 Digital Thermometer?

Digital Thermometer is a medical device that received FDA 510(k) clearance on 2016-08-29. The listed applicant is Biocare Asia Corporation , Ltd.. The 510(k) number is K161211.

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

Digital Thermometer received FDA 510(k) clearance on 2016-08-29, under 510(k) number K161211.

Who is the listed applicant for Digital Thermometer?

The FDA 510(k) record lists Biocare Asia Corporation , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Digital Thermometer?

The FDA product code for Digital Thermometer is FLL.

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Dispositivos Relacionados (Código: FLL)

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