FDA 510(k)

Technoweb Surgical Mask

Número K: K172500 · 2018-03-01

Data da decisão2018-03-01

Código do produtoFXX

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Technoweb Surgical Mask is the device name listed in this FDA 510(k) record. The listed applicant is Yts Global, Inc.. It received FDA 510(k) clearance on 2018-03-01 under 510(k) number K172500. The device is classified under product code FXX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Technoweb Surgical Mask?

Technoweb Surgical Mask is a medical device that received FDA 510(k) clearance on 2018-03-01. The listed applicant is Yts Global, Inc.. The 510(k) number is K172500.

When did Technoweb Surgical Mask receive FDA 510(k) clearance?

Technoweb Surgical Mask received FDA 510(k) clearance on 2018-03-01, under 510(k) number K172500.

Who is the listed applicant for Technoweb Surgical Mask?

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

What is the FDA product code for Technoweb Surgical Mask?

The FDA product code for Technoweb Surgical Mask is FXX.

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: FXX)

K251967HALYARD* FLUIDSHIELD* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops; HALYARD* FLUIDSHIELD* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops with WrapAround VisorO&M Halyard, Inc.K252534Surgical Face Mask (Ear mount)Zhejiang Hangkang Medical Equipment Co., Ltd.K253398Disposable Surgical Mask (Non-Sterile) (EFX3PLBLKMSK300)Efofex, Inc.K252830Disposable Surgical Face Mask (3P00B, C2900)Beatles Medical Supplies (Xiantao) Co., Ltd.K252650Disposable Medical Face MaskMakrite Industries, Inc.K243342KP Protective Face MaskKp Trading 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.