CoLumbo— 510(k) K220497

Substantially Equivalent

Smart Soft Healthcare AD

FDA 510(k) clearance K220497 for CoLumbo, Substantially Equivalent on 2022-06-23. Applicant: Smart Soft Healthcare AD.

Clearance details

Applicant: Smart Soft Healthcare AD
Product code: Code QIH
Advisory panel: Radiology
Date received: 2022-02-22
Decision date: 2022-06-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Varna, BG

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