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FDA 510(k)

Comfort Marker 2.0

N.º K: K222112 · 2023-03-30

SolicitanteMedical Precision BV
Fecha de decisión2023-03-30
Código de productoQRN
Comité asesorRA
DecisiónSubstantially Equivalent

Resumen del dispositivo

Comfort Marker 2.0 is the device name listed in this FDA 510(k) record. The listed applicant is Medical Precision BV. It received FDA 510(k) clearance on 2023-03-30 under 510(k) number K222112. The device is classified under product code QRN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Comfort Marker 2.0?

Comfort Marker 2.0 is a medical device that received FDA 510(k) clearance on 2023-03-30. The listed applicant is Medical Precision BV. The 510(k) number is K222112.

When did Comfort Marker 2.0 receive FDA 510(k) clearance?

Comfort Marker 2.0 received FDA 510(k) clearance on 2023-03-30, under 510(k) number K222112.

Who is the listed applicant for Comfort Marker 2.0?

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

What is the FDA product code for Comfort Marker 2.0?

The FDA product code for Comfort Marker 2.0 is QRN.

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Fuente oficial

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