FDA 510(k)

SunStim Peripheral Nerve Stimulator/Sunstim Plus Peripheral Nerve Stimulator

Номер K: K153045 · 2016-05-13

Дата решения2016-05-13

Код продуктаBXN

Консультативный комитетAN

РешениеSubstantially Equivalent

Описание устройства

SunStim Peripheral Nerve Stimulator/Sunstim Plus Peripheral Nerve Stimulator is the device name listed in this FDA 510(k) record. The listed applicant is Easy Med Instrument Co., Ltd.. It received FDA 510(k) clearance on 2016-05-13 under 510(k) number K153045. The device is classified under product code BXN. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the SunStim Peripheral Nerve Stimulator/Sunstim Plus Peripheral Nerve Stimulator?

SunStim Peripheral Nerve Stimulator/Sunstim Plus Peripheral Nerve Stimulator is a medical device that received FDA 510(k) clearance on 2016-05-13. The listed applicant is Easy Med Instrument Co., Ltd.. The 510(k) number is K153045.

When did SunStim Peripheral Nerve Stimulator/Sunstim Plus Peripheral Nerve Stimulator receive FDA 510(k) clearance?

SunStim Peripheral Nerve Stimulator/Sunstim Plus Peripheral Nerve Stimulator received FDA 510(k) clearance on 2016-05-13, under 510(k) number K153045.

Who is the listed applicant for SunStim Peripheral Nerve Stimulator/Sunstim Plus Peripheral Nerve Stimulator?

The FDA 510(k) record lists Easy Med Instrument Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SunStim Peripheral Nerve Stimulator/Sunstim Plus Peripheral Nerve Stimulator?

The FDA product code for SunStim Peripheral Nerve Stimulator/Sunstim Plus Peripheral Nerve Stimulator is BXN.

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: BXN)

K213049STIMPOD NMS450 Nerve StimulatorXavant Technology (Pty), Ltd.K162086MultiStim ECOPAJUNK GmbH Medizintechnologie

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.