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FDA 510(k)

FREEDOM Integrated Syringe Infusion System

N.º K: K200176 · 2021-12-15

SolicitanteRepro-Med Systems, Inc. Dba Koru Medical Systems
Fecha de decisión2021-12-15
Código de productoFRN
Comité asesorHO
DecisiónSubstantially Equivalent

Resumen del dispositivo

FREEDOM Integrated Syringe Infusion System is the device name listed in this FDA 510(k) record. The listed applicant is Repro-Med Systems, Inc. Dba Koru Medical Systems. It received FDA 510(k) clearance on 2021-12-15 under 510(k) number K200176. The device is classified under product code FRN. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the FREEDOM Integrated Syringe Infusion System?

FREEDOM Integrated Syringe Infusion System is a medical device that received FDA 510(k) clearance on 2021-12-15. The listed applicant is Repro-Med Systems, Inc. Dba Koru Medical Systems. The 510(k) number is K200176.

When did FREEDOM Integrated Syringe Infusion System receive FDA 510(k) clearance?

FREEDOM Integrated Syringe Infusion System received FDA 510(k) clearance on 2021-12-15, under 510(k) number K200176.

Who is the listed applicant for FREEDOM Integrated Syringe Infusion System?

The FDA 510(k) record lists Repro-Med Systems, Inc. Dba Koru Medical Systems as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FREEDOM Integrated Syringe Infusion System?

The FDA product code for FREEDOM Integrated Syringe Infusion System is FRN.

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Dispositivos relacionados (Código: FRN)

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.

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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.

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