FDA 510(k)

ShockPulse-SE Lithotripsy System

N.º K: K171024 · 2017-08-21

Fecha de decisión2017-08-21

Código de productoFEO

Comité asesorGU

DecisiónSubstantially Equivalent

Resumen del dispositivo

ShockPulse-SE Lithotripsy System is the device name listed in this FDA 510(k) record. The listed applicant is Cybersonics, Inc.. It received FDA 510(k) clearance on 2017-08-21 under 510(k) number K171024. The device is classified under product code FEO. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the ShockPulse-SE Lithotripsy System?

ShockPulse-SE Lithotripsy System is a medical device that received FDA 510(k) clearance on 2017-08-21. The listed applicant is Cybersonics, Inc.. The 510(k) number is K171024.

When did ShockPulse-SE Lithotripsy System receive FDA 510(k) clearance?

ShockPulse-SE Lithotripsy System received FDA 510(k) clearance on 2017-08-21, under 510(k) number K171024.

Who is the listed applicant for ShockPulse-SE Lithotripsy System?

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

What is the FDA product code for ShockPulse-SE Lithotripsy System?

The FDA product code for ShockPulse-SE Lithotripsy System is FEO.

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Fuente oficial

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