FDA 510(k)

NeuroSENSE Monitoring System, Model NS-901

Номер K: K202621 · 2021-08-05

Дата решения2021-08-05

Код продуктаOLW

Консультативный комитетNE

РешениеSubstantially Equivalent

Описание устройства

NeuroSENSE Monitoring System, Model NS-901 is the device name listed in this FDA 510(k) record. The listed applicant is Neurowave Systems, Inc.. It received FDA 510(k) clearance on 2021-08-05 under 510(k) number K202621. The device is classified under product code OLW. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the NeuroSENSE Monitoring System, Model NS-901?

NeuroSENSE Monitoring System, Model NS-901 is a medical device that received FDA 510(k) clearance on 2021-08-05. The listed applicant is Neurowave Systems, Inc.. The 510(k) number is K202621.

When did NeuroSENSE Monitoring System, Model NS-901 receive FDA 510(k) clearance?

NeuroSENSE Monitoring System, Model NS-901 received FDA 510(k) clearance on 2021-08-05, under 510(k) number K202621.

Who is the listed applicant for NeuroSENSE Monitoring System, Model NS-901?

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

What is the FDA product code for NeuroSENSE Monitoring System, Model NS-901?

The FDA product code for NeuroSENSE Monitoring System, Model NS-901 is OLW.

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: OLW)

K260907BIS™ Advance pEEG ModuleCovidien LP K260880SedLine Sedation MonitorMasimo Corporation K230693BIS™ Advance Monitoring SystemCovidien, LLC K213273Brain Anesthesia Response Monitor (Bar Monitor)Cortical Dynamics , Ltd.K203113Masimo SedLine Sedation Monitor and AccessoriesMasimo Corporation K172890SedLine Sedation MonitorMasimo Corporation

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.