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FDA 510(k)

One Touch

Número K: K181844 · 2019-04-15

RequerenteThai Nippon Rubber Industry Public Company, Ltd.
Data da decisão2019-04-15
Código do produtoHIS
Comité consultivoOB
DecisãoSubstantially Equivalent

Resumo do dispositivo

One Touch is the device name listed in this FDA 510(k) record. The listed applicant is Thai Nippon Rubber Industry Public Company, Ltd.. It received FDA 510(k) clearance on 2019-04-15 under 510(k) number K181844. The device is classified under product code HIS. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the One Touch?

One Touch is a medical device that received FDA 510(k) clearance on 2019-04-15. The listed applicant is Thai Nippon Rubber Industry Public Company, Ltd.. The 510(k) number is K181844.

When did One Touch receive FDA 510(k) clearance?

One Touch received FDA 510(k) clearance on 2019-04-15, under 510(k) number K181844.

Who is the listed applicant for One Touch?

The FDA 510(k) record lists Thai Nippon Rubber Industry Public Company, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for One Touch?

The FDA product code for One Touch is HIS.

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Fonte oficial

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