FDA 510(k)

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

K-Nummer: K160648 · 2016-08-10

Entscheidungsdatum2016-08-10

ProduktcodeFPA

BeratungsausschussHO

EntscheidungSubstantially Equivalent

Produktübersicht

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

Häufig gestellte Fragen

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. The listed applicant is Unomedical A/S. The 510(k) number is K160648.

When did MiniMed Quick-Set® MiniMed Sure-T® MiniMed Silhouette® MiniMed Mio® receive FDA 510(k) clearance?

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

Who is the listed applicant for MiniMed Quick-Set® MiniMed Sure-T® MiniMed Silhouette® MiniMed Mio®?

The FDA 510(k) record lists Unomedical A/S as the applicant. This does not by itself establish the device manufacturer.

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.

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Weitere Einträge mit Unomedical A/S als Antragsteller

K210544Medtronic Extended infusion set K192647neria guard Infusion Set K173879MiniMed Mio Advance infusion set K162812Unomedical Comfort Subkutane Infusionset, Unomedical Comfort Kurz Subkutane Infusionset, Unomedical Neria Soft Subkutane Infusionset, Medtronic Silhouette Subkutane Infusionset, Medtronic Silhouette Paradigm Subkutane Infusionset, Roche Accu-Chek Tender Subkutane Infusionset, Asante Comfort Subkutane Infusionset, Abbott Comfort Subkutane Infusionset

Verwandte Geräte (Code: FPA)

K254123Ecomed Disposable Administration SetsEcomed Solutions, LLC K261530iiSure Infusion SetDeka Research and Development K252543AMSafe Verabreichungssatz (BA-70075, BA-70071-D, BA-70070, BA-70071-P, BA-70072, BA-70072-F, BA-70071-DF, BA-70071-DF-120, FE01, FE04)Amsino International, Inc.K251375PuraCath Firefly Needleless Connector IT (9005)Puracath Medical, Inc.K251257nSet+ Stabilization Set [6426733]; nSet+ Stabilization Set with nSyte Needle Free Connector (NFC) [6426731]; nSyte Needle Free Connector (NFC) [6426727]Np Medical K250325BD Alaris Pump Infusion SetCarefusion (Bd)

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