FDA 510(k)

KidCap

Numéro K : K180568 · 2018-10-16

DemandeurEastern Cranial Affiliates, LLC

Date de décision2018-10-16

Code produitMVA

Comité consultatifNE

DécisionSubstantially Equivalent

Résumé du dispositif

KidCap is the device name listed in this FDA 510(k) record. The listed applicant is Eastern Cranial Affiliates, LLC. It received FDA 510(k) clearance on 2018-10-16 under 510(k) number K180568. The device is classified under product code MVA. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the KidCap?

KidCap is a medical device that received FDA 510(k) clearance on 2018-10-16. The listed applicant is Eastern Cranial Affiliates, LLC. The 510(k) number is K180568.

When did KidCap receive FDA 510(k) clearance?

KidCap received FDA 510(k) clearance on 2018-10-16, under 510(k) number K180568.

Who is the listed applicant for KidCap?

The FDA 510(k) record lists Eastern Cranial Affiliates, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for KidCap?

The FDA product code for KidCap is MVA.

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 : MVA)

K241957Talee, Talee PostOpInvent Medical USA, LLC K230444Talee, Talee PostOpInvent Medical USA, LLC K223238STARband 3DOrthomerica Products, Inc.K220681Talee, Talee PostOPInvent Medical USA, LLC K203134Hanger Cranial Band 3DSymbion Logistics, LLC K213587MyCRO BandOtto Bock Healthcare LP

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.