FDA 510(k)

ShockPulse-SE Lithotripsy System

Номер K: K171024 · 2017-08-21

Дата решения2017-08-21

Код продуктаFEO

Консультативный комитетGU

РешениеSubstantially Equivalent

Описание устройства

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.

Часто задаваемые вопросы

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.

Связанные клинические исследования

Связанные записи сопоставляются автоматически на основании названий, кодов продукции или иных метаданных. Сопоставление не подтверждает клиническую, научную, корпоративную или регуляторную связь; ознакомьтесь с официальными источниками по ссылкам.

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Связанные устройства (Код: FEO)

K230893Swiss LthoClast TrilogyE.M.S Electro Medical Systems S.A K182490Swiss LithoClast TrilogyE.M.S Electro Medical Systems S.A K181997Swiss LithoClast TrilogyE.M.S Electro Medical Systems S.A K181364Swiss LithoClast TrilogyE.M.S Electro Medical Systems S.A K173234Swiss LithoClast TrilogyE.M.S Electro Medical Systems S.A

Официальный источник

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