FDA 510(k)

Technoweb Surgical Mask

Numéro K : K172500 · 2018-03-01

Date de décision2018-03-01

Code produitFXX

Comité consultatifSU

DécisionSubstantially Equivalent

Résumé du dispositif

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.

Questions fréquentes

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.

Essais cliniques associés

Les enregistrements connexes sont mis en correspondance automatiquement à l'aide des noms, codes produits ou autres métadonnées. Une mise en correspondance n'établit pas de relation clinique, scientifique, corporative ou réglementaire vérifiée ; veuillez consulter les sources officielles liées.

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

Dispositifs connexes (Code : 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.

Source officielle

Voir dans la base de données FDA →

Données issues de l'API ouverte de la FDA. Pour les informations les plus récentes et faisant autorité, veuillez toujours vous référer au registre officiel.