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FDA 510(k)

Galaxy System

K-Number: K223144 · 2023-03-01

ApplicantNoah Medical Corp.
Decision Date2023-03-01
Product CodeEOQ
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

Galaxy System is a medical device manufactured by Noah Medical Corp.. It received FDA 510(k) clearance on 2023-03-01 under approval number K223144. The device is classified under product code EOQ. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Galaxy System?

Galaxy System is a medical device that received FDA 510(k) clearance on 2023-03-01. It is manufactured by Noah Medical Corp.. The 510(k) number is K223144.

When was Galaxy System approved by the FDA?

Galaxy System received FDA 510(k) clearance on 2023-03-01, under approval number K223144.

What company makes Galaxy System?

Galaxy System is manufactured by Noah Medical Corp..

What is the FDA product code for Galaxy System?

The FDA product code for Galaxy System is EOQ.

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Official Source

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