FDA 510(k)

EYE-SYNC

N.º K: K202927 · 2021-10-02

Fecha de decisión2021-10-02

Código de productoQEA

Comité asesorNE

DecisiónSubstantially Equivalent

Resumen del dispositivo

EYE-SYNC is the device name listed in this FDA 510(k) record. The listed applicant is Syncthink, Inc.. It received FDA 510(k) clearance on 2021-10-02 under 510(k) number K202927. The device is classified under product code QEA. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the EYE-SYNC?

EYE-SYNC is a medical device that received FDA 510(k) clearance on 2021-10-02. The listed applicant is Syncthink, Inc.. The 510(k) number is K202927.

When did EYE-SYNC receive FDA 510(k) clearance?

EYE-SYNC received FDA 510(k) clearance on 2021-10-02, under 510(k) number K202927.

Who is the listed applicant for EYE-SYNC?

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

What is the FDA product code for EYE-SYNC?

The FDA product code for EYE-SYNC is QEA.

Otros registros que enlistan a Syncthink, Inc. 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.

K152915EYE-SYNC

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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.