JAZZ Solo sensor
K-Number: K213637 · 2021-12-10
ApplicantJazz Imaging, LLC Dba Jazz Imaging
Decision Date2021-12-10
Product CodeMUH
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
JAZZ Solo sensor is a medical device manufactured by Jazz Imaging, LLC Dba Jazz Imaging. It received FDA 510(k) clearance on 2021-12-10 under approval number K213637. 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 2021-12-10. It is manufactured by Jazz Imaging, LLC Dba Jazz Imaging. The 510(k) number is K213637.
When was JAZZ Solo sensor approved by the FDA?
JAZZ Solo sensor received FDA 510(k) clearance on 2021-12-10, under approval number K213637.
What company makes JAZZ Solo sensor?
JAZZ Solo sensor is manufactured by Jazz Imaging, LLC Dba Jazz Imaging.
What is the FDA product code for JAZZ Solo sensor?
The FDA product code for JAZZ Solo sensor is MUH.
Related Devices (Code: MUH)
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.