FDA 510(k)

Acare Сuction Unit

Номер K: K182950 · 2019-08-23

Дата решения2019-08-23

Код продуктаJCX

Консультативный комитетSU

РешениеSubstantially Equivalent

Описание устройства

Acare Suction Unit is the device name listed in this FDA 510(k) record. The listed applicant is Acare Technology Co., Ltd.. It received FDA 510(k) clearance on 2019-08-23 under 510(k) number K182950. The device is classified under product code JCX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the Acare Suction Unit?

Acare Suction Unit is a medical device that received FDA 510(k) clearance on 2019-08-23. The listed applicant is Acare Technology Co., Ltd.. The 510(k) number is K182950.

When did Acare Suction Unit receive FDA 510(k) clearance?

Acare Suction Unit received FDA 510(k) clearance on 2019-08-23, under 510(k) number K182950.

Who is the listed applicant for Acare Suction Unit?

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

What is the FDA product code for Acare Suction Unit?

The FDA product code for Acare Suction Unit is JCX.

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: JCX)

K250964Protable Phlegm Suction Unit (JMA D01)Jiangsu Jumao X-Care Medical Equipment Co., Ltd.K243638MV Flow Aspiration Pump (MVFLOWPMP01)Microvention K251111CaryExcitus AS K243418Riptide™ Aspiration Pump; Riptide™ Collection Canister with Intermediate TubingMicro Therapeutics, Inc. d/b/a ev3 Neurovascular K233428Easycess Aspiration PumpGuangzhou Easycess Medical Co.,Ltd K222552120V Neptune S Rover (0711-001-000); V2 4-Port Manifold (0750-400-000); V2 Specimen Collection Manifold Kit (0750-200-000); V2 Specimen Collection Tray (0750-210-000)Stryker Instruments

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.