FDA 510(k)

Reverso

N.º K: K212107 · 2021-11-10

Fecha de decisión2021-11-10

Código de productoGEI

Comité asesorSU

DecisiónSubstantially Equivalent

Resumen del dispositivo

Reverso is the device name listed in this FDA 510(k) record. The listed applicant is Intelis Instruments , Ltd.. It received FDA 510(k) clearance on 2021-11-10 under 510(k) number K212107. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Reverso?

Reverso is a medical device that received FDA 510(k) clearance on 2021-11-10. The listed applicant is Intelis Instruments , Ltd.. The 510(k) number is K212107.

When did Reverso receive FDA 510(k) clearance?

Reverso received FDA 510(k) clearance on 2021-11-10, under 510(k) number K212107.

Who is the listed applicant for Reverso?

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

What is the FDA product code for Reverso?

The FDA product code for Reverso is GEI.

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