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FDA 510(k)

MiniMed Quick-Set® MiniMed Sure-T® MiniMed Silhouette® MiniMed Mio®

K-Number: K160648 · 2016-08-10

ApplicantUnomedical A/S
Decision Date2016-08-10
Product CodeFPA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

MiniMed Quick-Set® MiniMed Sure-T® MiniMed Silhouette® MiniMed Mio® is a medical device manufactured by Unomedical A/S. It received FDA 510(k) clearance on 2016-08-10 under approval number K160648. The device is classified under product code FPA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MiniMed Quick-Set® MiniMed Sure-T® MiniMed Silhouette® MiniMed Mio®?

MiniMed Quick-Set® MiniMed Sure-T® MiniMed Silhouette® MiniMed Mio® is a medical device that received FDA 510(k) clearance on 2016-08-10. It is manufactured by Unomedical A/S. The 510(k) number is K160648.

When was MiniMed Quick-Set® MiniMed Sure-T® MiniMed Silhouette® MiniMed Mio® approved by the FDA?

MiniMed Quick-Set® MiniMed Sure-T® MiniMed Silhouette® MiniMed Mio® received FDA 510(k) clearance on 2016-08-10, under approval number K160648.

What company makes MiniMed Quick-Set® MiniMed Sure-T® MiniMed Silhouette® MiniMed Mio®?

MiniMed Quick-Set® MiniMed Sure-T® MiniMed Silhouette® MiniMed Mio® is manufactured by Unomedical A/S.

What is the FDA product code for MiniMed Quick-Set® MiniMed Sure-T® MiniMed Silhouette® MiniMed Mio®?

The FDA product code for MiniMed Quick-Set® MiniMed Sure-T® MiniMed Silhouette® MiniMed Mio® is FPA.

Other Devices by Unomedical A/S

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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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