Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

MU2net

K-Number: K191944 · 2019-10-24

ApplicantDosisoft
Decision Date2019-10-24
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MU2net is a medical device manufactured by Dosisoft. It received FDA 510(k) clearance on 2019-10-24 under approval number K191944. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MU2net?

MU2net is a medical device that received FDA 510(k) clearance on 2019-10-24. It is manufactured by Dosisoft. The 510(k) number is K191944.

When was MU2net approved by the FDA?

MU2net received FDA 510(k) clearance on 2019-10-24, under approval number K191944.

What company makes MU2net?

MU2net is manufactured by Dosisoft.

What is the FDA product code for MU2net?

The FDA product code for MU2net is IYE.

Other Devices by Dosisoft

K180106ThinkQA K182966PLANET Onco Dose

Related Devices (Code: IYE)

K162476Varian High Energy Linear AcceleratorVarian Medical Systems, Inc. K161400ImagingRing SystemMedphoton GmbH K162468ClearCheckRadformation K162355Raycast MammoRx Carbon Fibre Breast BoardOrfit Industries NV K162577Dosimetry Check Version 5 Release 1Math Resolutions, LLC K162265CushionCast Moldable CushionsIzi Medical Products, LLC

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.

↑