FDA 510(k)

ELECTROCYN soma

Numéro K : K220286 · 2022-12-21

Date de décision2022-12-21

Code produitFRO

DécisionSubstantially Equivalent

Résumé du dispositif

ELECTROCYN soma is the device name listed in this FDA 510(k) record. The listed applicant is V3Bio Sdn. Bhd. It received FDA 510(k) clearance on 2022-12-21 under 510(k) number K220286. The device is classified under product code FRO. Product code FRO falls under the category of Anesthesiology, which includes devices for anesthetic delivery and patient monitoring. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the ELECTROCYN soma?

ELECTROCYN soma is a medical device that received FDA 510(k) clearance on 2022-12-21. The listed applicant is V3Bio Sdn. Bhd. The 510(k) number is K220286.

When did ELECTROCYN soma receive FDA 510(k) clearance?

ELECTROCYN soma received FDA 510(k) clearance on 2022-12-21, under 510(k) number K220286.

Who is the listed applicant for ELECTROCYN soma?

The FDA 510(k) record lists V3Bio Sdn. Bhd as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ELECTROCYN soma?

The FDA product code for ELECTROCYN soma is FRO. This falls under the Anesthesiology category.

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 : FRO)

K254168Actolind® (06.3637. Actolind® Gel Plus)ACTO GmbH K254041SkinSmart Antimicrobial HydroGelMagic Science Supply, LLC K261646Redermax® Antibacterial Wound MatrixBeijing Kreate Medical Co., Ltd.K253665Vashe Plus Antimicrobial SolutionUrgo Medical North America, LLC K251929SilverCeuticals® Antimicrobial Wound GelSilverceuticals, Inc.K261023Microdacyn Wound Irrigation SolutionSonoma Pharmaceuticals, Inc.

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.