FDA 510(k)

AI100 com Shonit

Número K: K221309 · 2023-09-19

RequerenteSigtuple Technologies Pvt. , Ltd.

Data da decisão2023-09-19

Código do produtoJOY

Comité consultivoHE

DecisãoSubstantially Equivalent

Resumo do dispositivo

AI100 with Shonit is the device name listed in this FDA 510(k) record. The listed applicant is Sigtuple Technologies Pvt. , Ltd.. It received FDA 510(k) clearance on 2023-09-19 under 510(k) number K221309. The device is classified under product code JOY. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the AI100 with Shonit?

AI100 with Shonit is a medical device that received FDA 510(k) clearance on 2023-09-19. The listed applicant is Sigtuple Technologies Pvt. , Ltd.. The 510(k) number is K221309.

When did AI100 with Shonit receive FDA 510(k) clearance?

AI100 with Shonit received FDA 510(k) clearance on 2023-09-19, under 510(k) number K221309.

Who is the listed applicant for AI100 with Shonit?

The FDA 510(k) record lists Sigtuple Technologies Pvt. , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AI100 with Shonit?

The FDA product code for AI100 with Shonit is JOY.

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: JOY)

K243144X100/X100HT with Full Field Peripheral Blood Smear (PBS) ApplicationScopio Labs , Ltd.K220013X100HT with Slide Loader with Full Field Peripheral Blood Smear (PBS) ApplicationScopio Labs , Ltd.K200595CellaVision DC-1, CellaVision DC-1 PPACellaVision AB K201301X100 with Full Field Peripheral Blood Smear (PBS) ApplicationScopio Labs , Ltd.K182062Sysmex UD-10, Fully Automated Urine Particle Digital Imaging DeviceSysmex America, Inc.K171315Aplicação Avançada de Eritrocitos (RBC)CellaVision AB

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.