FDA 510(k)

HeRO Symphony, HeRO ES, HeRO solo/duet

N.º K: K180242 · 2018-02-28

SolicitanteMedical Predictive Science Corporation

Fecha de decisión2018-02-28

Código de productoDPS

Comité asesorCV

DecisiónSubstantially Equivalent

Resumen del dispositivo

HeRO Symphony, HeRO ES, HeRO solo/duet is the device name listed in this FDA 510(k) record. The listed applicant is Medical Predictive Science Corporation. It received FDA 510(k) clearance on 2018-02-28 under 510(k) number K180242. The device is classified under product code DPS. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the HeRO Symphony, HeRO ES, HeRO solo/duet?

HeRO Symphony, HeRO ES, HeRO solo/duet is a medical device that received FDA 510(k) clearance on 2018-02-28. The listed applicant is Medical Predictive Science Corporation. The 510(k) number is K180242.

When did HeRO Symphony, HeRO ES, HeRO solo/duet receive FDA 510(k) clearance?

HeRO Symphony, HeRO ES, HeRO solo/duet received FDA 510(k) clearance on 2018-02-28, under 510(k) number K180242.

Who is the listed applicant for HeRO Symphony, HeRO ES, HeRO solo/duet?

The FDA 510(k) record lists Medical Predictive Science Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HeRO Symphony, HeRO ES, HeRO solo/duet?

The FDA product code for HeRO Symphony, HeRO ES, HeRO solo/duet is DPS.

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