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)

Boston Keratoprosthesis, Type I Lucia

Número K: K182986 · 2019-01-30

RequerenteMassachusetts Eye and Ear Infirmary D/B/A Boston
Data da decisão2019-01-30
Código do produtoHQM
Comité consultivoOP
DecisãoSubstantially Equivalent

Resumo do dispositivo

Boston Keratoprosthesis, Type I Lucia is the device name listed in this FDA 510(k) record. The listed applicant is Massachusetts Eye and Ear Infirmary D/B/A Boston. It received FDA 510(k) clearance on 2019-01-30 under 510(k) number K182986. The device is classified under product code HQM. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Boston Keratoprosthesis, Type I Lucia?

Boston Keratoprosthesis, Type I Lucia is a medical device that received FDA 510(k) clearance on 2019-01-30. The listed applicant is Massachusetts Eye and Ear Infirmary D/B/A Boston. The 510(k) number is K182986.

When did Boston Keratoprosthesis, Type I Lucia receive FDA 510(k) clearance?

Boston Keratoprosthesis, Type I Lucia received FDA 510(k) clearance on 2019-01-30, under 510(k) number K182986.

Who is the listed applicant for Boston Keratoprosthesis, Type I Lucia?

The FDA 510(k) record lists Massachusetts Eye and Ear Infirmary D/B/A Boston as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Boston Keratoprosthesis, Type I Lucia?

The FDA product code for Boston Keratoprosthesis, Type I Lucia is HQM.

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.

↑