Bella-mu
K-Number: K190962 · 2020-02-03
ApplicantU-Needle B.V.
Decision Date2020-02-03
Product CodeFMI
Advisory CommitteeHO
DecisionSubstantially Equivalent
Device Summary
Bella-mu is a medical device manufactured by U-Needle B.V.. It received FDA 510(k) clearance on 2020-02-03 under approval number K190962. The device is classified under product code FMI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Bella-mu?
Bella-mu is a medical device that received FDA 510(k) clearance on 2020-02-03. It is manufactured by U-Needle B.V.. The 510(k) number is K190962.
When was Bella-mu approved by the FDA?
Bella-mu received FDA 510(k) clearance on 2020-02-03, under approval number K190962.
What company makes Bella-mu?
Bella-mu is manufactured by U-Needle B.V..
What is the FDA product code for Bella-mu?
The FDA product code for Bella-mu is FMI.
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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.