Aviso: Este site agrega dados públicos oficiais da FDA, ClinicalTrials.gov, PubMed e SEC EDGAR apenas para referência geral. Não constitui aconselhamento médico, diagnóstico, recomendação de tratamento ou aconselhamento de investimento.

FDA 510(k)

Biolinq Shine Autonomous Time-in-Range Microsensor

Número K: K262599 · 2026-09-18

RequerenteBiolinq Incorporated
Data da decisão2026-09-18
Código do produtoSFU
Comité consultivoCH
DecisãoSubstantially Equivalent

Resumo do dispositivo

Biolinq Shine Autonomous Time-in-Range Microsensor is the device name listed in this FDA 510(k) record. The listed applicant is Biolinq Incorporated. It received FDA 510(k) clearance on 2026-09-18 under 510(k) number K262599. The device is classified under product code SFU. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Biolinq Shine Autonomous Time-in-Range Microsensor?

Biolinq Shine Autonomous Time-in-Range Microsensor is a medical device that received FDA 510(k) clearance on 2026-09-18. The listed applicant is Biolinq Incorporated. The 510(k) number is K262599.

When did Biolinq Shine Autonomous Time-in-Range Microsensor receive FDA 510(k) clearance?

Biolinq Shine Autonomous Time-in-Range Microsensor received FDA 510(k) clearance on 2026-09-18, under 510(k) number K262599.

Who is the listed applicant for Biolinq Shine Autonomous Time-in-Range Microsensor?

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

What is the FDA product code for Biolinq Shine Autonomous Time-in-Range Microsensor?

The FDA product code for Biolinq Shine Autonomous Time-in-Range Microsensor is SFU.

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_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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.

↑