FDA 510(k)

AiSteth®

Número K: K252915 · 2026-05-22

RequerenteAi Health Highway India Pvt., Ltd.

Data da decisão2026-05-22

Código do produtoDQD

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

AiSteth® is the device name listed in this FDA 510(k) record. The listed applicant is Ai Health Highway India Pvt., Ltd.. It received FDA 510(k) clearance on 2026-05-22 under 510(k) number K252915. The device is classified under product code DQD. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the AiSteth®?

AiSteth® is a medical device that received FDA 510(k) clearance on 2026-05-22. The listed applicant is Ai Health Highway India Pvt., Ltd.. The 510(k) number is K252915.

When did AiSteth® receive FDA 510(k) clearance?

AiSteth® received FDA 510(k) clearance on 2026-05-22, under 510(k) number K252915.

Who is the listed applicant for AiSteth®?

The FDA 510(k) record lists Ai Health Highway India Pvt., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AiSteth®?

The FDA product code for AiSteth® is DQD.

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: DQD)

K261494Smart Wireless Stethoscope (STEMO310);Smart Wireless Stethoscope (STEMO710);Smart Wireless Stethoscope (STEMO720);Smart Wireless Stethoscope (STEMO730)Shanghai Hulu Devices Co., Ltd.K261694CORE 300 Digital StethoscopeEko Health, Inc.K252089Tyto Stethoscope (G3)Tyto Care , Ltd.K252076Kneevoice Cartilage Evaluation System (750-3600-001)Kneevoice, Inc.K252284eMurmur Heart AICsd Labs K252595Stethophone ProSparrow Acoustics, 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.