FDA 510(k)

PADnet Xpress

Numéro K : K220527 · 2022-10-20

DemandeurCollaborative Care Diagnostics, LLC, D.B.A. Biomedix

Date de décision2022-10-20

Code produitJOM

Comité consultatifCV

DécisionSubstantially Equivalent

Résumé du dispositif

PADnet Xpress is the device name listed in this FDA 510(k) record. The listed applicant is Collaborative Care Diagnostics, LLC, D.B.A. Biomedix. It received FDA 510(k) clearance on 2022-10-20 under 510(k) number K220527. The device is classified under product code JOM. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the PADnet Xpress?

PADnet Xpress is a medical device that received FDA 510(k) clearance on 2022-10-20. The listed applicant is Collaborative Care Diagnostics, LLC, D.B.A. Biomedix. The 510(k) number is K220527.

When did PADnet Xpress receive FDA 510(k) clearance?

PADnet Xpress received FDA 510(k) clearance on 2022-10-20, under 510(k) number K220527.

Who is the listed applicant for PADnet Xpress?

The FDA 510(k) record lists Collaborative Care Diagnostics, LLC, D.B.A. Biomedix as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PADnet Xpress?

The FDA product code for PADnet Xpress is JOM.

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 : JOM)

K213730MESI mTABLET TBI diagnostic system, MESI mTABLET TBIMesi, Development of Medical Devices, Ltd.; Mesi D.O.O.K200567Analyseur de plethysmographie ASIArterial Stiffness, Inc.K201046Automated ankle brachial pressure index measuring device, MESI mTABLET systemMesi D.O.O.; Mesi, Development of Medical Devices, Ltd.K191266VitalScan ANSMedeia, Inc.K172655Automated ankle brachial pressure index measuring deviceMesi D.O.O.; Mesi, Development of Medical Devices, Ltd.K173696TBL-ABI SystemLd Technology, 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.