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FDA 510(k)

Plasmage System

K-Number: K202106 · 2022-04-06

ApplicantBrera Medical, Inc.
Decision Date2022-04-06
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Plasmage System is a medical device manufactured by Brera Medical, Inc.. It received FDA 510(k) clearance on 2022-04-06 under approval number K202106. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Plasmage System?

Plasmage System is a medical device that received FDA 510(k) clearance on 2022-04-06. It is manufactured by Brera Medical, Inc.. The 510(k) number is K202106.

When was Plasmage System approved by the FDA?

Plasmage System received FDA 510(k) clearance on 2022-04-06, under approval number K202106.

What company makes Plasmage System?

Plasmage System is manufactured by Brera Medical, Inc..

What is the FDA product code for Plasmage System?

The FDA product code for Plasmage System is GEI.

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Official Source

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