FDA 510(k)

Thermoforming Sheet Materials

Numéro K : K200125 · 2020-10-28

Date de décision2020-10-28

Code produitMQC

DécisionSubstantially Equivalent

Résumé du dispositif

Thermoforming Sheet Materials is the device name listed in this FDA 510(k) record. The listed applicant is Erkodent Erich Kopp GmbH. It received FDA 510(k) clearance on 2020-10-28 under 510(k) number K200125. The device is classified under product code MQC. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the Thermoforming Sheet Materials?

Thermoforming Sheet Materials is a medical device that received FDA 510(k) clearance on 2020-10-28. The listed applicant is Erkodent Erich Kopp GmbH. The 510(k) number is K200125.

When did Thermoforming Sheet Materials receive FDA 510(k) clearance?

Thermoforming Sheet Materials received FDA 510(k) clearance on 2020-10-28, under 510(k) number K200125.

Who is the listed applicant for Thermoforming Sheet Materials?

The FDA 510(k) record lists Erkodent Erich Kopp GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Thermoforming Sheet Materials?

The FDA product code for Thermoforming Sheet Materials is MQC.

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 : MQC)

K253798UltraPrint-Dental Hard Splint UVGuangzhou Heygears IMC., Inc.K250743Remvia NightGuardRemvia K251252NOBILCAM IMPAK DiscShandong Huge Dental Material Corporation K241729Hard Splint & Thermo-Adaptive SplintWhip Mix Corporation K243516Remi Custom Night GuardGrindguard, Inc.K241369LIJIA Night GuardLijia, LLC

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.