FDA 510(k)

SONON Ultrasound Imaging System, Model: 300L

Número K: K170085 · 2017-10-12

Data da decisão2017-10-12

Código do produtoIYN

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

SONON Ultrasound Imaging System, Model: 300L is the device name listed in this FDA 510(k) record. The listed applicant is Healcerion Co., Ltd.. It received FDA 510(k) clearance on 2017-10-12 under 510(k) number K170085. The device is classified under product code IYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the SONON Ultrasound Imaging System, Model: 300L?

SONON Ultrasound Imaging System, Model: 300L is a medical device that received FDA 510(k) clearance on 2017-10-12. The listed applicant is Healcerion Co., Ltd.. The 510(k) number is K170085.

When did SONON Ultrasound Imaging System, Model: 300L receive FDA 510(k) clearance?

SONON Ultrasound Imaging System, Model: 300L received FDA 510(k) clearance on 2017-10-12, under 510(k) number K170085.

Who is the listed applicant for SONON Ultrasound Imaging System, Model: 300L?

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

What is the FDA product code for SONON Ultrasound Imaging System, Model: 300L?

The FDA product code for SONON Ultrasound Imaging System, Model: 300L is IYN.

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

Outros registros que listam Healcerion Co., Ltd. como candidato(a)

K211665SONON Ultrasound Imaging System, Model: SONON300C K212400SONON Ultrasound Imaging System, Model: SONON 500L

Dispositivos Relacionados (Código: IYN)

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.