FDA 510(k)

MED RF 4000

N.º K: K210077 · 2021-12-17

Fecha de decisión2021-12-17

Código de productoONQ

Comité asesorSU

DecisiónSubstantially Equivalent

Resumen del dispositivo

MED RF 4000 is the device name listed in this FDA 510(k) record. The listed applicant is F Care Systems USA, LLC. It received FDA 510(k) clearance on 2021-12-17 under 510(k) number K210077. The device is classified under product code ONQ. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the MED RF 4000?

MED RF 4000 is a medical device that received FDA 510(k) clearance on 2021-12-17. The listed applicant is F Care Systems USA, LLC. The 510(k) number is K210077.

When did MED RF 4000 receive FDA 510(k) clearance?

MED RF 4000 received FDA 510(k) clearance on 2021-12-17, under 510(k) number K210077.

Who is the listed applicant for MED RF 4000?

The FDA 510(k) record lists F Care Systems USA, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MED RF 4000?

The FDA product code for MED RF 4000 is ONQ.

Otros registros que enlistan a F Care Systems USA, LLC como solicitante

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.

K253918Veineo System (00MEDRF4000TCUS 05CR45iT 06Pedal1St)K252704F Care RF System (00MEDRF4000US, 05RAFAELOPROBE, 05SPHERAPROBE, 06OUTPUTKAB, 06Pedal1St)K220725HPR45i

Fuente oficial

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