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FDA 510(k)

JAZZ SOLO Sensor

K-Number: K163224 · 2017-03-09

ApplicantJazz Imaging, LLC
Decision Date2017-03-09
Product CodeMUH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

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

Frequently Asked Questions

What is the JAZZ SOLO Sensor?

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

When was JAZZ SOLO Sensor approved by the FDA?

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

What company makes JAZZ SOLO Sensor?

JAZZ SOLO Sensor is manufactured by Jazz Imaging, LLC.

What is the FDA product code for JAZZ SOLO Sensor?

The FDA product code for JAZZ SOLO Sensor is MUH.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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