CoLumboX— 510(k) K250367

Substantially Equivalent

Smart Soft Healthcare AD

FDA 510(k) clearance K250367 for CoLumboX, Substantially Equivalent on 2025-05-28. Applicant: Smart Soft Healthcare AD.

Clearance details

Applicant: Smart Soft Healthcare AD
Product code: Code QIH
Advisory panel: Radiology
Date received: 2025-02-10
Decision date: 2025-05-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Varna, BG

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