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FDA 510(k)

One Touch

N.º K: K181844 · 2019-04-15

SolicitanteThai Nippon Rubber Industry Public Company, Ltd.
Fecha de decisión2019-04-15
Código de productoHIS
Comité asesorOB
DecisiónSubstantially Equivalent

Resumen del 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.

Preguntas frecuentes

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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Dispositivos relacionados (Código: HIS)

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Fuente oficial

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Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.

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