FDA 510(k)

SOTA Cloud Smart Sensor (1.5)

Número K: K251793 · 2026-03-03

Data da decisão2026-03-03

Código do produtoMUH

Comité consultivoDE

DecisãoSubstantially Equivalent

Resumo do dispositivo

SOTA Cloud Smart Sensor (1.5) is the device name listed in this FDA 510(k) record. The listed applicant is Sota Cloud Corp.. It received FDA 510(k) clearance on 2026-03-03 under 510(k) number K251793. The device is classified under product code MUH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the SOTA Cloud Smart Sensor (1.5)?

SOTA Cloud Smart Sensor (1.5) is a medical device that received FDA 510(k) clearance on 2026-03-03. The listed applicant is Sota Cloud Corp.. The 510(k) number is K251793.

When did SOTA Cloud Smart Sensor (1.5) receive FDA 510(k) clearance?

SOTA Cloud Smart Sensor (1.5) received FDA 510(k) clearance on 2026-03-03, under 510(k) number K251793.

Who is the listed applicant for SOTA Cloud Smart Sensor (1.5)?

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

What is the FDA product code for SOTA Cloud Smart Sensor (1.5)?

The FDA product code for SOTA Cloud Smart Sensor (1.5) is MUH.

Ensaios clínicos relacionados

Registros relacionados são pareados automaticamente usando nomes, códigos de produtos ou outros metadados. Um pareamento não estabelece um vínculo clínico, científico, corporativo ou regulatório verificado; revise as fontes oficiais vinculadas.

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

Dispositivos Relacionados (Código: MUH)

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.K241649DUO1 and DUO2Zinnovi, Inc.

Fonte oficial

Ver na base de dados da FDA →

Dados provenientes da FDA Open API. Para informações mais recentes e oficiais, consulte sempre o registro oficial.