FDA 510(k)

DripAssist Plus

Número K: K172242 · 2018-05-25

Data da decisão2018-05-25

Código do produtoFLN

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

DripAssist Plus is the device name listed in this FDA 510(k) record. The listed applicant is Shift Labs, Inc.. It received FDA 510(k) clearance on 2018-05-25 under 510(k) number K172242. The device is classified under product code FLN. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the DripAssist Plus?

DripAssist Plus is a medical device that received FDA 510(k) clearance on 2018-05-25. The listed applicant is Shift Labs, Inc.. The 510(k) number is K172242.

When did DripAssist Plus receive FDA 510(k) clearance?

DripAssist Plus received FDA 510(k) clearance on 2018-05-25, under 510(k) number K172242.

Who is the listed applicant for DripAssist Plus?

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

What is the FDA product code for DripAssist Plus?

The FDA product code for DripAssist Plus is FLN.

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

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.