Decision Date2020-02-03
Product CodeFMI
Advisory CommitteeHO
DecisionSubstantially Equivalent
Device Summary
Bella-mu is the device name listed in this FDA 510(k) record. The listed applicant is U-Needle B.V.. It received FDA 510(k) clearance on 2020-02-03 under 510(k) 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. The listed applicant is U-Needle B.V.. The 510(k) number is K190962.
When did Bella-mu receive FDA 510(k) clearance?
Bella-mu received FDA 510(k) clearance on 2020-02-03, under 510(k) number K190962.
Who is the listed applicant for Bella-mu?
The FDA 510(k) record lists U-Needle B.V. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Bella-mu?
The FDA product code for Bella-mu is FMI.
Related Devices (Code: FMI)
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
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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.