FDA 510(k)

Integrity V500 (Integrity, Integrity with VEMP)

Номер K: K242954 · 2024-12-19

Дата решения2024-12-19

Код продуктаGWJ

Консультативный комитетNE

РешениеSubstantially Equivalent

Описание устройства

Integrity V500 (Integrity, Integrity with VEMP) is the device name listed in this FDA 510(k) record. The listed applicant is Vivosonic, Inc.. It received FDA 510(k) clearance on 2024-12-19 under 510(k) number K242954. The device is classified under product code GWJ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the Integrity V500 (Integrity, Integrity with VEMP)?

Integrity V500 (Integrity, Integrity with VEMP) is a medical device that received FDA 510(k) clearance on 2024-12-19. The listed applicant is Vivosonic, Inc.. The 510(k) number is K242954.

When did Integrity V500 (Integrity, Integrity with VEMP) receive FDA 510(k) clearance?

Integrity V500 (Integrity, Integrity with VEMP) received FDA 510(k) clearance on 2024-12-19, under 510(k) number K242954.

Who is the listed applicant for Integrity V500 (Integrity, Integrity with VEMP)?

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

What is the FDA product code for Integrity V500 (Integrity, Integrity with VEMP)?

The FDA product code for Integrity V500 (Integrity, Integrity with VEMP) is GWJ.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Связанные устройства (Код: GWJ)

K233649ALGO_Pro_Новый_рожденный_Слух_Скринер_(ALGO_Pro)Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)K220139QScreenPath Medical GmbH K211147ALGO_7iPath Medical GmbH K193033GSI Audera ProGrason Stadler K163326SmartEPIntelligent Hearing Systems K162037Eclipse with VEMPInteracoustics A/S

Официальный источник

Посмотреть в базе данных FDA →

Данные получены из открытого API FDA. Для получения наиболее актуальной и авторитетной информации всегда обращайтесь к официальным записям.