Koios DS— 510(k) K212616

Substantially Equivalent

Koios Medical, Inc.

FDA 510(k) clearance K212616 for Koios DS, Substantially Equivalent on 2021-12-16. Applicant: Koios Medical, Inc..

Clearance details

Applicant: Koios Medical, Inc.
Product code: Code POK
Advisory panel: Radiology
Date received: 2021-08-18
Decision date: 2021-12-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: New York, NY, US

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