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FDA 510(k)

Physiotrace

N.º K: K171244 · 2017-08-23

SolicitanteNimbleheart, Inc.
Fecha de decisión2017-08-23
Código de productoDRX
Comité asesorCV
DecisiónSubstantially Equivalent

Resumen del dispositivo

Physiotrace is the device name listed in this FDA 510(k) record. The listed applicant is Nimbleheart, Inc.. It received FDA 510(k) clearance on 2017-08-23 under 510(k) number K171244. The device is classified under product code DRX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Physiotrace?

Physiotrace is a medical device that received FDA 510(k) clearance on 2017-08-23. The listed applicant is Nimbleheart, Inc.. The 510(k) number is K171244.

When did Physiotrace receive FDA 510(k) clearance?

Physiotrace received FDA 510(k) clearance on 2017-08-23, under 510(k) number K171244.

Who is the listed applicant for Physiotrace?

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

What is the FDA product code for Physiotrace?

The FDA product code for Physiotrace is DRX.

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Fuente oficial

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