FDA 510(k)

ShockPulse-SE Lithotripsy System

Numéro K : K171024 · 2017-08-21

Date de décision2017-08-21

Code produitFEO

Comité consultatifGU

DécisionSubstantially Equivalent

Résumé du dispositif

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.

Questions fréquentes

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.

Essais cliniques associés

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Dispositifs connexes (Code : FEO)

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Source officielle

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