FDA 510(k)

Panoura X-ERA PF/NF/MF

Número K: K182198 · 2019-01-31

RequerenteThe Yoshida Dental Mfg. Co., Ltd.

Data da decisão2019-01-31

Código do produtoMUH

Comité consultivoDE

DecisãoSubstantially Equivalent

Resumo do dispositivo

Panoura X-ERA PF/NF/MF is the device name listed in this FDA 510(k) record. The listed applicant is The Yoshida Dental Mfg. Co., Ltd.. It received FDA 510(k) clearance on 2019-01-31 under 510(k) number K182198. The device is classified under product code MUH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Panoura X-ERA PF/NF/MF?

Panoura X-ERA PF/NF/MF is a medical device that received FDA 510(k) clearance on 2019-01-31. The listed applicant is The Yoshida Dental Mfg. Co., Ltd.. The 510(k) number is K182198.

When did Panoura X-ERA PF/NF/MF receive FDA 510(k) clearance?

Panoura X-ERA PF/NF/MF received FDA 510(k) clearance on 2019-01-31, under 510(k) number K182198.

Who is the listed applicant for Panoura X-ERA PF/NF/MF?

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

What is the FDA product code for Panoura X-ERA PF/NF/MF?

The FDA product code for Panoura X-ERA PF/NF/MF is MUH.

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: MUH)

K251793SOTA Cloud Smart Sensor (1.5)Sota Cloud Corp.K252570EzSensor HD, EzSensor UHDQpix Solutions, Inc.K250687Cocoon Solo (DX-7020s)Dexcowin Global, Inc.K251206Digital X-Ray DentiMax Pro Imaging SystemDentimax, Inc.K240040VistaPano S Ceph 2.0 (VistaPano S Ceph); VistaPano S 2.0 (VistaPano S); ProVecta S-Pan Ceph 2.0 (ProVecta S-Pan Ceph); ProVecta S-Pan 2.0 (ProVecta S-Pan)VATECH Co., Ltd.K242778X Sensor (Model: IOS-A15IF, HDI-15DGF)Qpix Solutions, Inc.

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.