Akesis Galaxy— 510(k) K190844

Substantially Equivalent

Akesis, Inc.

FDA 510(k) clearance K190844 for Akesis Galaxy, Substantially Equivalent on 2019-09-04. Applicant: Akesis, Inc..

Clearance details

Applicant: Akesis, Inc.
Product code: Code IWB
Advisory panel: Radiology
Date received: 2019-04-01
Decision date: 2019-09-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Concord, CA, US

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