FDA 510(k)

Zurich Pressure Guidewire System Model 100

Номер K: K190852 · 2019-08-14

Дата решения2019-08-14

Код продуктаDXO

Консультативный комитетCV

РешениеSubstantially Equivalent

Описание устройства

Zurich Pressure Guidewire System Model 100 is the device name listed in this FDA 510(k) record. The listed applicant is Zurich Medical, Inc.. It received FDA 510(k) clearance on 2019-08-14 under 510(k) number K190852. The device is classified under product code DXO. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the Zurich Pressure Guidewire System Model 100?

Zurich Pressure Guidewire System Model 100 is a medical device that received FDA 510(k) clearance on 2019-08-14. The listed applicant is Zurich Medical, Inc.. The 510(k) number is K190852.

When did Zurich Pressure Guidewire System Model 100 receive FDA 510(k) clearance?

Zurich Pressure Guidewire System Model 100 received FDA 510(k) clearance on 2019-08-14, under 510(k) number K190852.

Who is the listed applicant for Zurich Pressure Guidewire System Model 100?

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

What is the FDA product code for Zurich Pressure Guidewire System Model 100?

The FDA product code for Zurich Pressure Guidewire System Model 100 is DXO.

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: DXO)

K251367OptoMonitor 3Opsens, Inc.K241418OptoMonitor 3Opsens, Inc.K233904ACIST RXi Система (016616); ACIST Navvus II Катетер (016675_Acist Medical Systems, Inc.K222216TruWave Disposable Pressure TransducerEdwards Lifesciences, LLC K202943OptoMonitor 3Opsens, Inc.K193620OptoMonitor 3Opsens, Inc.

Официальный источник

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