FDA 510(k)

Breast Volume Navigator (BVN) Model G-2000

Номер K: K211098 · 2021-05-26

Дата решения2021-05-26

Код продуктаIYO

Консультативный комитетRA

РешениеSubstantially Equivalent

Описание устройства

Breast Volume Navigator (BVN) Model G-2000 is the device name listed in this FDA 510(k) record. The listed applicant is Metritrack, Inc.. It received FDA 510(k) clearance on 2021-05-26 under 510(k) number K211098. The device is classified under product code IYO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the Breast Volume Navigator (BVN) Model G-2000?

Breast Volume Navigator (BVN) Model G-2000 is a medical device that received FDA 510(k) clearance on 2021-05-26. The listed applicant is Metritrack, Inc.. The 510(k) number is K211098.

When did Breast Volume Navigator (BVN) Model G-2000 receive FDA 510(k) clearance?

Breast Volume Navigator (BVN) Model G-2000 received FDA 510(k) clearance on 2021-05-26, under 510(k) number K211098.

Who is the listed applicant for Breast Volume Navigator (BVN) Model G-2000?

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

What is the FDA product code for Breast Volume Navigator (BVN) Model G-2000?

The FDA product code for Breast Volume Navigator (BVN) Model G-2000 is IYO.

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: IYO)

K260313MD-6000S Bladder ScannerMEDA Co., Ltd.K253452Accuro 3SRivanna Medical, Inc.K260190ARTHURROPCA ApS K252237EdgeFlow UW20Edgecare, Inc.K254021Accuro XVRivanna Medical, Inc.K253898QT Scanner 2000 Model AQT Imaging Holdings, Inc.

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.