FDA 510(k)

S698 Symbioz flow

N.º K: K153367 · 2016-06-17

Fecha de decisión2016-06-17

Código de productoHIF

Comité asesorOB

DecisiónSubstantially Equivalent

Resumen del dispositivo

S698 Symbioz flow is the device name listed in this FDA 510(k) record. The listed applicant is Sopro - Acteon Group. It received FDA 510(k) clearance on 2016-06-17 under 510(k) number K153367. The device is classified under product code HIF. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the S698 Symbioz flow?

S698 Symbioz flow is a medical device that received FDA 510(k) clearance on 2016-06-17. The listed applicant is Sopro - Acteon Group. The 510(k) number is K153367.

When did S698 Symbioz flow receive FDA 510(k) clearance?

S698 Symbioz flow received FDA 510(k) clearance on 2016-06-17, under 510(k) number K153367.

Who is the listed applicant for S698 Symbioz flow?

The FDA 510(k) record lists Sopro - Acteon Group as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for S698 Symbioz flow?

The FDA product code for S698 Symbioz flow is HIF.

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Fuente oficial

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