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)

Visibly Digital Acuity Product

Número K: K220090 · 2022-08-12

RequerenteVisibly, Inc.
Data da decisão2022-08-12
Código do produtoQTO
Comité consultivoOP
DecisãoSubstantially Equivalent

Resumo do dispositivo

Visibly Digital Acuity Product is the device name listed in this FDA 510(k) record. The listed applicant is Visibly, Inc.. It received FDA 510(k) clearance on 2022-08-12 under 510(k) number K220090. The device is classified under product code QTO. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Visibly Digital Acuity Product?

Visibly Digital Acuity Product is a medical device that received FDA 510(k) clearance on 2022-08-12. The listed applicant is Visibly, Inc.. The 510(k) number is K220090.

When did Visibly Digital Acuity Product receive FDA 510(k) clearance?

Visibly Digital Acuity Product received FDA 510(k) clearance on 2022-08-12, under 510(k) number K220090.

Who is the listed applicant for Visibly Digital Acuity Product?

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

What is the FDA product code for Visibly Digital Acuity Product?

The FDA product code for Visibly Digital Acuity Product is QTO.

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.

↑