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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 the device name listed in this FDA 510(k) record. The listed applicant is Unomedical A/S. It received FDA 510(k) clearance on 2019-12-13 under 510(k) 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. The listed applicant is Unomedical A/S. The 510(k) number is K192647.

When did neria guard Infusion Set receive FDA 510(k) clearance?

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

Who is the listed applicant for neria guard Infusion Set?

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 neria guard Infusion Set?

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

Other records listing Unomedical A/S as applicant

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.

K210544Medtronic Extended infusion setK173879MiniMed Mio Advance infusion setK162812Unomedical 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 SetK160648MiniMed Quick-Set® MiniMed Sure-T® MiniMed Silhouette® MiniMed Mio®

Related Devices (Code: FPA)

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.

K261530iiSure Infusion SetDeka Research and DevelopmentK252543AMSafe Administration Set (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 MedicalK250325BD Alaris Pump Infusion SetCarefusion (Bd)K251814EZ™ IV Administration SetEpic Medical Pte. , Ltd.

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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