FDA 510(k)

Breast Volume Navigator (BVN) Model G-2000

N.º K: K211098 · 2021-05-26

Fecha de decisión2021-05-26

Código de productoIYO

Comité asesorRA

DecisiónSubstantially Equivalent

Resumen del dispositivo

Breast Volume Navigator (BVN) Model G-2000 is the device name listed in this FDA 510(k) record. The listed applicant is Metritrack, Inc.. It received FDA 510(k) clearance on 2021-05-26 under 510(k) number K211098. The device is classified under product code IYO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Breast Volume Navigator (BVN) Model G-2000?

Breast Volume Navigator (BVN) Model G-2000 is a medical device that received FDA 510(k) clearance on 2021-05-26. The listed applicant is Metritrack, Inc.. The 510(k) number is K211098.

When did Breast Volume Navigator (BVN) Model G-2000 receive FDA 510(k) clearance?

Breast Volume Navigator (BVN) Model G-2000 received FDA 510(k) clearance on 2021-05-26, under 510(k) number K211098.

Who is the listed applicant for Breast Volume Navigator (BVN) Model G-2000?

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

What is the FDA product code for Breast Volume Navigator (BVN) Model G-2000?

The FDA product code for Breast Volume Navigator (BVN) Model G-2000 is IYO.

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Fuente oficial

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