FDA 510(k)

JAZZ Solo sensor

N.º K: K213637 · 2021-12-10

SolicitanteJazz Imaging, LLC Dba Jazz Imaging

Fecha de decisión2021-12-10

Código de productoMUH

Comité asesorDE

DecisiónSubstantially Equivalent

Resumen del dispositivo

JAZZ Solo sensor is the device name listed in this FDA 510(k) record. The listed applicant is Jazz Imaging, LLC Dba Jazz Imaging. It received FDA 510(k) clearance on 2021-12-10 under 510(k) number K213637. The device is classified under product code MUH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the JAZZ Solo sensor?

JAZZ Solo sensor is a medical device that received FDA 510(k) clearance on 2021-12-10. The listed applicant is Jazz Imaging, LLC Dba Jazz Imaging. The 510(k) number is K213637.

When did JAZZ Solo sensor receive FDA 510(k) clearance?

JAZZ Solo sensor received FDA 510(k) clearance on 2021-12-10, under 510(k) number K213637.

Who is the listed applicant for JAZZ Solo sensor?

The FDA 510(k) record lists Jazz Imaging, LLC Dba Jazz Imaging as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for JAZZ Solo sensor?

The FDA product code for JAZZ Solo sensor is MUH.

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