FDA 510(k)

D²RS and D²RS 9090

N.º K: K221335 · 2022-06-07

Fecha de decisión2022-06-07

Código de productoOWB

Comité asesorRA

DecisiónSubstantially Equivalent

Resumen del dispositivo

D²RS and D²RS 9090 is the device name listed in this FDA 510(k) record. The listed applicant is Stephanix. It received FDA 510(k) clearance on 2022-06-07 under 510(k) number K221335. The device is classified under product code OWB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the D²RS and D²RS 9090?

D²RS and D²RS 9090 is a medical device that received FDA 510(k) clearance on 2022-06-07. The listed applicant is Stephanix. The 510(k) number is K221335.

When did D²RS and D²RS 9090 receive FDA 510(k) clearance?

D²RS and D²RS 9090 received FDA 510(k) clearance on 2022-06-07, under 510(k) number K221335.

Who is the listed applicant for D²RS and D²RS 9090?

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

What is the FDA product code for D²RS and D²RS 9090?

The FDA product code for D²RS and D²RS 9090 is OWB.

Otros registros que enlistan a Stephanix 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.

K213479D²RS and D²RS 9090 K212515MOVIX DReamy

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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.