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FDA 510(k)

Akesis Galaxy

K-Number: K190844 · 2019-09-04

ApplicantAkesis, Inc.
Decision Date2019-09-04
Product CodeIWB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Akesis Galaxy is a medical device manufactured by Akesis, Inc.. It received FDA 510(k) clearance on 2019-09-04 under approval number K190844. The device is classified under product code IWB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Akesis Galaxy?

Akesis Galaxy is a medical device that received FDA 510(k) clearance on 2019-09-04. It is manufactured by Akesis, Inc.. The 510(k) number is K190844.

When was Akesis Galaxy approved by the FDA?

Akesis Galaxy received FDA 510(k) clearance on 2019-09-04, under approval number K190844.

What company makes Akesis Galaxy?

Akesis Galaxy is manufactured by Akesis, Inc..

What is the FDA product code for Akesis Galaxy?

The FDA product code for Akesis Galaxy is IWB.

Other Devices by Akesis, Inc.

K200050Akesis Galaxy RTx K203146Akesis Galaxy RTi

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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