FDA 510(k)

AISAP Cardio V1.0

Numéro K : K234141 · 2024-08-01

DemandeurAisap

Date de décision2024-08-01

Code produitPOK

Comité consultatifRA

DécisionSubstantially Equivalent

Résumé du dispositif

AISAP Cardio V1.0 is the device name listed in this FDA 510(k) record. The listed applicant is Aisap. It received FDA 510(k) clearance on 2024-08-01 under 510(k) number K234141. The device is classified under product code POK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the AISAP Cardio V1.0?

AISAP Cardio V1.0 is a medical device that received FDA 510(k) clearance on 2024-08-01. The listed applicant is Aisap. The 510(k) number is K234141.

When did AISAP Cardio V1.0 receive FDA 510(k) clearance?

AISAP Cardio V1.0 received FDA 510(k) clearance on 2024-08-01, under 510(k) number K234141.

Who is the listed applicant for AISAP Cardio V1.0?

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

What is the FDA product code for AISAP Cardio V1.0?

The FDA product code for AISAP Cardio V1.0 is POK.

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 : POK)

K253884Koios DS (3.8)Koios Medical, Inc.K261519Sonio SuspectSonio K254161Automated Aortic Stenosis Software (AutoAS)GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC K251769RevealAI-LungPrecision Medical Ventures, Inc. Dba Revealdx K252294Fetal EchoScan (v1.2)Brightheart K250221StrokeSENS ASPECTS Software ApplicationCircle Cardiovascular Imaging, 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.