CoLumbo— 510(k) K241211

Substantially Equivalent

Smart Soft Healthcare

FDA 510(k) clearance K241211 for CoLumbo, Substantially Equivalent on 2024-08-15. Applicant: Smart Soft Healthcare. Device class: 2.

Clearance details

Applicant: Smart Soft Healthcare
Product code: Code QIH
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 2024-04-30
Decision date: 2024-08-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Varna, BG

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.