FDA 510(k)

Philips wearable biosensor-G5 Solution

Номер K: K181165 · 2019-03-07

ЗаявительConnected Sensing- A Division of Philips Medical Systems

Дата решения2019-03-07

Код продуктаDRT

Консультативный комитетCV

РешениеSubstantially Equivalent

Описание устройства

Philips wearable biosensor-G5 Solution is the device name listed in this FDA 510(k) record. The listed applicant is Connected Sensing- A Division of Philips Medical Systems. It received FDA 510(k) clearance on 2019-03-07 under 510(k) number K181165. The device is classified under product code DRT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the Philips wearable biosensor-G5 Solution?

Philips wearable biosensor-G5 Solution is a medical device that received FDA 510(k) clearance on 2019-03-07. The listed applicant is Connected Sensing- A Division of Philips Medical Systems. The 510(k) number is K181165.

When did Philips wearable biosensor-G5 Solution receive FDA 510(k) clearance?

Philips wearable biosensor-G5 Solution received FDA 510(k) clearance on 2019-03-07, under 510(k) number K181165.

Who is the listed applicant for Philips wearable biosensor-G5 Solution?

The FDA 510(k) record lists Connected Sensing- A Division of Philips Medical Systems as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Philips wearable biosensor-G5 Solution?

The FDA product code for Philips wearable biosensor-G5 Solution is DRT.

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: DRT)

K254058DistaSense(TM) (v1)Life Detection Technologies K261286The Circadia C300 System (C300)Circadia Health, Inc.K252676The Circadia C300 System (C300)Circadia Health, Inc.K253388Sleepiz One+ (Model 2.5)Sleepiz AG K251364Sleepiz One+ (2.5)Sleepiz AG K234003The Circadia C200 SystemCircadia Technologies, Ltd.

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.