FDA 510(k)

CO2 Laser Machine, Model: BW-203B

Número K: K211735 · 2021-10-22

RequerenteZhengzhou Bestview ST Co., Ltd.

Data da decisão2021-10-22

Código do produtoGEX

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

CO2 Laser Machine, Model: BW-203B is the device name listed in this FDA 510(k) record. The listed applicant is Zhengzhou Bestview ST Co., Ltd.. It received FDA 510(k) clearance on 2021-10-22 under 510(k) number K211735. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the CO2 Laser Machine, Model: BW-203B?

CO2 Laser Machine, Model: BW-203B is a medical device that received FDA 510(k) clearance on 2021-10-22. The listed applicant is Zhengzhou Bestview ST Co., Ltd.. The 510(k) number is K211735.

When did CO2 Laser Machine, Model: BW-203B receive FDA 510(k) clearance?

CO2 Laser Machine, Model: BW-203B received FDA 510(k) clearance on 2021-10-22, under 510(k) number K211735.

Who is the listed applicant for CO2 Laser Machine, Model: BW-203B?

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

What is the FDA product code for CO2 Laser Machine, Model: BW-203B?

The FDA product code for CO2 Laser Machine, Model: BW-203B is GEX. This falls under the Gastroenterology category.

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 Zhengzhou Bestview ST Co., Ltd. como candidato(a)

K211335Diode Laser Machine, Model Number: BM-100

Dispositivos Relacionados (Código: GEX)

K254199PicoreMax (PicoreMax)BLUECORE COMPANY Co., Ltd.K252723Dynamis Pro FamilyFotona D.O.O.K241973SmartIPL_NI SystemLumenis Be, Ltd.K261047Dental Diode Laser Device (Laser-Pen)Guilin Kevin Peter Technology Co., Ltd.K261817Diode Laser Therapy System (PZ-BDT67-01, PZ-BDT67-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.K261673LED Therapy Device (QLXY-01)Beijing Nubway S&T Co., Ltd.

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.