FDA 510(k)

JAZZ SOLO Sensor

Número K: K163224 · 2017-03-09

Data da decisão2017-03-09

Código do produtoMUH

Comité consultivoDE

DecisãoSubstantially Equivalent

Resumo do dispositivo

JAZZ SOLO Sensor is the device name listed in this FDA 510(k) record. The listed applicant is Jazz Imaging, LLC. It received FDA 510(k) clearance on 2017-03-09 under 510(k) number K163224. The device is classified under product code MUH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the JAZZ SOLO Sensor?

JAZZ SOLO Sensor is a medical device that received FDA 510(k) clearance on 2017-03-09. The listed applicant is Jazz Imaging, LLC. The 510(k) number is K163224.

When did JAZZ SOLO Sensor receive FDA 510(k) clearance?

JAZZ SOLO Sensor received FDA 510(k) clearance on 2017-03-09, under 510(k) number K163224.

Who is the listed applicant for JAZZ SOLO Sensor?

The FDA 510(k) record lists Jazz Imaging, LLC 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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