FDA 510(k)

Le logiciel MySOZO version 6.1.0.1 (version SW 6.1.0.1) est un dispositif médical qui a reçu l'approbation FDA 510(k) le 2026-08-17. Le demandeur inscrit est ImpediMed Limited. Le numéro 510(k) est K260224.

Numéro K : K252439 · 2026-05-01

DemandeurDongguan Tutamen Metalwork Co., Ltd.

Date de décision2026-05-01

Code produitGXY

Comité consultatifNE

DécisionSubstantially Equivalent

Résumé du dispositif

Tutamen Self Adhesive Electrodes is the device name listed in this FDA 510(k) record. The listed applicant is Dongguan Tutamen Metalwork Co., Ltd.. It received FDA 510(k) clearance on 2026-05-01 under 510(k) number K252439. The device is classified under product code GXY. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the Tutamen Self Adhesive Electrodes?

Tutamen Self Adhesive Electrodes is a medical device that received FDA 510(k) clearance on 2026-05-01. The listed applicant is Dongguan Tutamen Metalwork Co., Ltd.. The 510(k) number is K252439.

When did Tutamen Self Adhesive Electrodes receive FDA 510(k) clearance?

Tutamen Self Adhesive Electrodes received FDA 510(k) clearance on 2026-05-01, under 510(k) number K252439.

Who is the listed applicant for Tutamen Self Adhesive Electrodes?

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

What is the FDA product code for Tutamen Self Adhesive Electrodes?

The FDA product code for Tutamen Self Adhesive Electrodes is GXY.

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

Autres dossiers indiquant Dongguan Tutamen Metalwork Co., Ltd. en tant que demandeur

K240472PBM Hair Therapy Cap

Dispositifs connexes (Code : GXY)

K262654Dexus Prosthetic System (MSL2, MSR2)Zhejiang Qiangnao Technology Co.,Ltd K260578Ambu® NeurolineTM Cup MRI/CT (Modèles 72704/21US, 72704/23US, 72704/25US, 72704/27US) Ambu® NeurolineTM Cup MRI/CT-set (Modèles 72704/21-1010US, 72704/21-1010US, 72704/23-1010US, 72704/25-1010US, 72704/27-1010US) Ambu® NeurolineTM Cup MRI/CT-mini set (Modèles 72704/21-0301US, 72704/23-0301US, 72704/25-0301US, 72704/27-0301US)Ambu A/S K261442Charlotte ACC25 Surface Electrode Array; Charlotte ACC25 Reusable Surface Electrode ArrayCadwell Industries, Inc.K261522BioWave BioWrapsBiowave Corporation K253237Elde Medical Electrodes (T5/ 5 cm x 5cm electrode T10/ 5 cm x 10cm electrode)Elde Medikal Sanayi ve Ticaret Anonim Sirketi K254183MR Conditional Cup ElectrodesTechnomed Europe

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.