FDA 510(k)

PtoleMedic System

N.º K: K202521 · 2021-05-04

SolicitanteLento Medical Innovation, Inc.

Fecha de decisión2021-05-04

Código de productoLLZ

Comité asesorRA

DecisiónSubstantially Equivalent

Resumen del dispositivo

PtoleMedic System is the device name listed in this FDA 510(k) record. The listed applicant is Lento Medical Innovation, Inc.. It received FDA 510(k) clearance on 2021-05-04 under 510(k) number K202521. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the PtoleMedic System?

PtoleMedic System is a medical device that received FDA 510(k) clearance on 2021-05-04. The listed applicant is Lento Medical Innovation, Inc.. The 510(k) number is K202521.

When did PtoleMedic System receive FDA 510(k) clearance?

PtoleMedic System received FDA 510(k) clearance on 2021-05-04, under 510(k) number K202521.

Who is the listed applicant for PtoleMedic System?

The FDA 510(k) record lists Lento Medical Innovation, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PtoleMedic System?

The FDA product code for PtoleMedic System is LLZ.

Ensayos clínicos relacionados

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

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

Dispositivos relacionados (Código: LLZ)

K261874Syneris PACS v.1.0.1.0Syneris K262442HipStudio AnalysisReplasia BV K261855Elucid PlaqueIQElucid Bioimaging, Inc.K254214OOOPDSTaiwan Main Orthopaedic Biotechnology Co., Ltd.K261861SPINEsim v1.0Mdsim S.A.K2620603D-RD-SRadiopharmaceutical Imaging & Dosimetry, LLC

Fuente oficial

Ver en la base de datos de la FDA →

Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.