FDA 510(k)

DC-Air and Athlos-1 and Athlos-Air

Номер K: K211688 · 2021-07-22

ЗаявительAthlos OY

Дата решения2021-07-22

Код продуктаMUH

Консультативный комитетDE

РешениеSubstantially Equivalent

Описание устройства

DC-Air and Athlos-1 and Athlos-Air is the device name listed in this FDA 510(k) record. The listed applicant is Athlos OY. It received FDA 510(k) clearance on 2021-07-22 under 510(k) number K211688. The device is classified under product code MUH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the DC-Air and Athlos-1 and Athlos-Air?

DC-Air and Athlos-1 and Athlos-Air is a medical device that received FDA 510(k) clearance on 2021-07-22. The listed applicant is Athlos OY. The 510(k) number is K211688.

When did DC-Air and Athlos-1 and Athlos-Air receive FDA 510(k) clearance?

DC-Air and Athlos-1 and Athlos-Air received FDA 510(k) clearance on 2021-07-22, under 510(k) number K211688.

Who is the listed applicant for DC-Air and Athlos-1 and Athlos-Air?

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

What is the FDA product code for DC-Air and Athlos-1 and Athlos-Air?

The FDA product code for DC-Air and Athlos-1 and Athlos-Air is MUH.

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: MUH)

K251793SOTA Cloud Smart Sensor (1.5)Sota Cloud Corp.K252570EzSensor HD, EzSensor UHDQpix Solutions, Inc.K250687Cocoon Solo (DX-7020s)Dexcowin Global, Inc.K251206Digital X-Ray DentiMax Pro Imaging SystemDentimax, Inc.K240040VistaPano S Ceph 2.0 (VistaPano S Ceph); VistaPano S 2.0 (VistaPano S); ProVecta S-Pan Ceph 2.0 (ProVecta S-Pan Ceph); ProVecta S-Pan 2.0 (ProVecta S-Pan)VATECH Co., Ltd.K242778X Sensor (Model: IOS-A15IF, HDI-15DGF)Qpix Solutions, 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.