FDA 510(k)

XV Lung Ventilation Analysis Software

Номер K: K193293 · 2020-05-14

Заявитель4Dx Limited

Дата решения2020-05-14

Код продуктаJAK

Консультативный комитетRA

РешениеSubstantially Equivalent

Описание устройства

XV Lung Ventilation Analysis Software is the device name listed in this FDA 510(k) record. The listed applicant is 4Dx Limited. It received FDA 510(k) clearance on 2020-05-14 under 510(k) number K193293. The device is classified under product code JAK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the XV Lung Ventilation Analysis Software?

XV Lung Ventilation Analysis Software is a medical device that received FDA 510(k) clearance on 2020-05-14. The listed applicant is 4Dx Limited. The 510(k) number is K193293.

When did XV Lung Ventilation Analysis Software receive FDA 510(k) clearance?

XV Lung Ventilation Analysis Software received FDA 510(k) clearance on 2020-05-14, under 510(k) number K193293.

Who is the listed applicant for XV Lung Ventilation Analysis Software?

The FDA 510(k) record lists 4Dx Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for XV Lung Ventilation Analysis Software?

The FDA product code for XV Lung Ventilation Analysis Software is JAK.

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: JAK)

K261125BodyTom 64 (NL4100); OmniTom Elite (NL5000)Samsung HME America, Inc., dba NeuroLogica Corp.K261229SCENARIA View Phase 6.0Fujifilm Corporation K253836FCT iStream Phase 2Fujifilm Corporation K253450BodyTom Elite (NL4000)NeuroLogica Corp., a Samsung Company K253770CardIQ SuiteGE Medical Systems SCS K253560Enhanced Boundary for PCCTGe Medical Systems, LLC

Официальный источник

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