FDA 510(k)

SAM Model 9-10000

N.º K: K240100 · 2024-06-04

Fecha de decisión2024-06-04

Código de productoMNR

Comité asesorIt appears you've provided the instruction but not the source text to translate. Please paste the English medical-device regulatory text you'd like translated into Spanish, and I'll translate it while preserving company/product names, FDA, 510(k), PMA, NCT, PMID, identifiers, and URLs.

DecisiónSubstantially Equivalent

Resumen del dispositivo

SAM Model 9-10000 is the device name listed in this FDA 510(k) record. The listed applicant is Snap Diagnostics, LLC. It received FDA 510(k) clearance on 2024-06-04 under 510(k) number K240100. The device is classified under product code MNR. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the SAM Model 9-10000?

SAM Model 9-10000 is a medical device that received FDA 510(k) clearance on 2024-06-04. The listed applicant is Snap Diagnostics, LLC. The 510(k) number is K240100.

When did SAM Model 9-10000 receive FDA 510(k) clearance?

SAM Model 9-10000 received FDA 510(k) clearance on 2024-06-04, under 510(k) number K240100.

Who is the listed applicant for SAM Model 9-10000?

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

What is the FDA product code for SAM Model 9-10000?

The FDA product code for SAM Model 9-10000 is MNR.

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 NCT07095751Sistema de Evaluación de Catéter Uro-Cam Asistido por Inteligencia Artificial para el Diagnóstico de Cáncer de VésículaNOT_YET_RECRUITING

Dispositivos relacionados (Código: MNR)

K260949Cinturones desechables para Polisomnografía (CNSAC)CNSAC Medshop GmbH K254042WatchPAT SWItamar Medical , Ltd.K260050WRAP SystemHuneo, LLC K253148RX-1 SleepVivaquant, Inc. Dba Rhythm Express K252628CASSIEWesper, Inc.K252497SANSA HSATHuxley Medical

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.