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FDA 510(k)

neria guard Infusion Set

K-Number: K192647 · 2019-12-13

ApplicantUnomedical A/S
Decision Date2019-12-13
Product CodeFPA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

neria guard Infusion Set is a medical device manufactured by Unomedical A/S. It received FDA 510(k) clearance on 2019-12-13 under approval number K192647. 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 neria guard Infusion Set?

neria guard Infusion Set is a medical device that received FDA 510(k) clearance on 2019-12-13. It is manufactured by Unomedical A/S. The 510(k) number is K192647.

When was neria guard Infusion Set approved by the FDA?

neria guard Infusion Set received FDA 510(k) clearance on 2019-12-13, under approval number K192647.

What company makes neria guard Infusion Set?

neria guard Infusion Set is manufactured by Unomedical A/S.

What is the FDA product code for neria guard Infusion Set?

The FDA product code for neria guard Infusion Set is FPA.

Other Devices by Unomedical A/S

K160648MiniMed Quick-Set® MiniMed Sure-T® MiniMed Silhouette® MiniMed Mio® K162812Unomedical Comfort Subcutaneous Infusion Set, Unomedical Comfort Short Subcutaneous Infusion Set, Unomedical Neria Soft Subcutaneous Infusion Set, Medtronic Silhouette Subcutaneous Infusion Set, Medtronic Silhouette Paradigm Subcutaneous Infusion Set, Roche Accu-Chek Tender Subcutaneous Infusion Set, Asante Comfort Subcutaneous Infusion Set, Abbott Comfort Subcutaneous Infusion Set K173879MiniMed Mio Advance infusion set K210544Medtronic Extended infusion set

Related Devices (Code: FPA)

K160007Paclitaxel SetsBaxter Healthcare Corporation K162304Q2 Multiport IV Administration Sets and Extension Sets, Checkmate Multiport IV Administration Sets, Q2 Extension SetsQuest Medical, Inc. K161323Solution Set for Epidural UseBaxter Healthcare Corporation K153731LifeFlow Rapid Infusion Device (LifeFlow Device)410 Medical Innovation, LLC K153440PowerLoc MAX Power Injectable Infusion Set, SafeStep Huber Needle SetC.R. Bard, Inc. K160648MiniMed Quick-Set® MiniMed Sure-T® MiniMed Silhouette® MiniMed Mio®Unomedical A/S

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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