FDA 510(k)

My Dose Coach

N.º K: K163099 · 2017-03-22

Fecha de decisión2017-03-22

Código de productoNDC

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DecisiónSubstantially Equivalent

Resumen del dispositivo

My Dose Coach is the device name listed in this FDA 510(k) record. The listed applicant is Sanofi, Inc.. It received FDA 510(k) clearance on 2017-03-22 under 510(k) number K163099. The device is classified under product code NDC. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the My Dose Coach?

My Dose Coach is a medical device that received FDA 510(k) clearance on 2017-03-22. The listed applicant is Sanofi, Inc.. The 510(k) number is K163099.

When did My Dose Coach receive FDA 510(k) clearance?

My Dose Coach received FDA 510(k) clearance on 2017-03-22, under 510(k) number K163099.

Who is the listed applicant for My Dose Coach?

The FDA 510(k) record lists Sanofi, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for My Dose Coach?

The FDA product code for My Dose Coach is NDC.

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Fuente oficial

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