FDA 510(k)

Sistema de Monitoreo Accuryn, Sistema de Placa de Temporización de UO SmartFoley IAP 12 F, Sistema de Placa de Temporización de UO SmartFoley IAP 14 F

N.º K: K221020 · 2023-01-13

Fecha de decisión2023-01-13

Código de productoEZL

Comité asesorGU

DecisiónUnknown

Resumen del dispositivo

Accuryn Monitoring System, Accuryn SmartFoley IAP UO Temp Tray System 12 F, Accuryn SmartFoley IAP UO Temp Tray System 14 F is the device name listed in this FDA 510(k) record. The listed applicant is Potrero Medical, Inc.. It received FDA 510(k) clearance on 2023-01-13 under 510(k) number K221020. The device is classified under product code EZL. It was reviewed by the GU advisory panel. FDA Decision: Unknown.

Preguntas frecuentes

What is the Accuryn Monitoring System, Accuryn SmartFoley IAP UO Temp Tray System 12 F, Accuryn SmartFoley IAP UO Temp Tray System 14 F?

Accuryn Monitoring System, Accuryn SmartFoley IAP UO Temp Tray System 12 F, Accuryn SmartFoley IAP UO Temp Tray System 14 F is a medical device that received FDA 510(k) clearance on 2023-01-13. The listed applicant is Potrero Medical, Inc.. The 510(k) number is K221020.

When did Accuryn Monitoring System, Accuryn SmartFoley IAP UO Temp Tray System 12 F, Accuryn SmartFoley IAP UO Temp Tray System 14 F receive FDA 510(k) clearance?

Accuryn Monitoring System, Accuryn SmartFoley IAP UO Temp Tray System 12 F, Accuryn SmartFoley IAP UO Temp Tray System 14 F received FDA 510(k) clearance on 2023-01-13, under 510(k) number K221020.

Who is the listed applicant for Accuryn Monitoring System, Accuryn SmartFoley IAP UO Temp Tray System 12 F, Accuryn SmartFoley IAP UO Temp Tray System 14 F?

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

What is the FDA product code for Accuryn Monitoring System, Accuryn SmartFoley IAP UO Temp Tray System 12 F, Accuryn SmartFoley IAP UO Temp Tray System 14 F?

The FDA product code for Accuryn Monitoring System, Accuryn SmartFoley IAP UO Temp Tray System 12 F, Accuryn SmartFoley IAP UO Temp Tray System 14 F is EZL.

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Otros registros que enlistan a Potrero Medical, Inc. como solicitante

K153655Sistema de Monitoreo Accuryn

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Fuente oficial

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