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FDA 510(k)

Matrix Pre-Treatment Controller

N.º K: K161844 · 2016-12-13

SolicitanteBetter Water, LLC
Fecha de decisión2016-12-13
Código de productoFIP
Comité asesorGU
DecisiónSubstantially Equivalent

Resumen del dispositivo

Matrix Pre-Treatment Controller is the device name listed in this FDA 510(k) record. The listed applicant is Better Water, LLC. It received FDA 510(k) clearance on 2016-12-13 under 510(k) number K161844. The device is classified under product code FIP. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Matrix Pre-Treatment Controller?

Matrix Pre-Treatment Controller is a medical device that received FDA 510(k) clearance on 2016-12-13. The listed applicant is Better Water, LLC. The 510(k) number is K161844.

When did Matrix Pre-Treatment Controller receive FDA 510(k) clearance?

Matrix Pre-Treatment Controller received FDA 510(k) clearance on 2016-12-13, under 510(k) number K161844.

Who is the listed applicant for Matrix Pre-Treatment Controller?

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

What is the FDA product code for Matrix Pre-Treatment Controller?

The FDA product code for Matrix Pre-Treatment Controller is FIP.

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Dispositivos relacionados (Código: FIP)

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

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Fuente oficial

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