FDA 510(k)

Delphi Stimulator

Номер K: K242345 · 2024-11-05

Дата решения2024-11-05

Код продуктаGWF

Консультативный комитетNE

РешениеSubstantially Equivalent

Описание устройства

Delphi Stimulator is the device name listed in this FDA 510(k) record. The listed applicant is Quantalx Neuroscience. It received FDA 510(k) clearance on 2024-11-05 under 510(k) number K242345. The device is classified under product code GWF. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the Delphi Stimulator?

Delphi Stimulator is a medical device that received FDA 510(k) clearance on 2024-11-05. The listed applicant is Quantalx Neuroscience. The 510(k) number is K242345.

When did Delphi Stimulator receive FDA 510(k) clearance?

Delphi Stimulator received FDA 510(k) clearance on 2024-11-05, under 510(k) number K242345.

Who is the listed applicant for Delphi Stimulator?

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

What is the FDA product code for Delphi Stimulator?

The FDA product code for Delphi Stimulator is GWF.

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: GWF)

K263010ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpressinomed Medizintechnik GmbH K253301BraiN20® (BraiN20)Time IS Brain, S.L.K252842SafeOp 3: Neural Informatix SystemAlphatec Spine, Inc.K243982Nicolet EDXNatus Neurology Incorporated K243495Natus Ultrapro S100 (982A0594)Natus Neurology Incorporated K234092SafeOp 3: Neural Informatix SysteemAlphatec Spine, 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.