FDA 510(k)

TruGuard Custom Tongue and Jaw Positioner

Numéro K : K153270 · 2016-03-08

Date de décision2016-03-08

Code produitIYE

Comité consultatifRA

DécisionSubstantially Equivalent

Résumé du dispositif

TruGuard Custom Tongue and Jaw Positioner is the device name listed in this FDA 510(k) record. The listed applicant is Bionix Development Corp.. It received FDA 510(k) clearance on 2016-03-08 under 510(k) number K153270. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the TruGuard Custom Tongue and Jaw Positioner?

TruGuard Custom Tongue and Jaw Positioner is a medical device that received FDA 510(k) clearance on 2016-03-08. The listed applicant is Bionix Development Corp.. The 510(k) number is K153270.

When did TruGuard Custom Tongue and Jaw Positioner receive FDA 510(k) clearance?

TruGuard Custom Tongue and Jaw Positioner received FDA 510(k) clearance on 2016-03-08, under 510(k) number K153270.

Who is the listed applicant for TruGuard Custom Tongue and Jaw Positioner?

The FDA 510(k) record lists Bionix Development Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TruGuard Custom Tongue and Jaw Positioner?

The FDA product code for TruGuard Custom Tongue and Jaw Positioner is IYE.

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 : IYE)

K261865AerFrame™ Alignment Laser Box (LBV2)Stabilix, LLC K261718EZFluence (RADEZ V2)Radformation, Inc.K260733MRIA Radiation Therapy Information System (MRIA)Manteia Technologies Co., Ltd.K261856Halcyon, Ethos Radiotherapy System (5.0)Varian Medical Systems, Inc.K252937ThinkQA 3Dosisoft SA K253004LUNA 3DLap GmbH Laser Applikationen

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.