TribusConnect— 510(k) K242166

Substantially Equivalent

Tribusmed Beheer BV

FDA 510(k) clearance K242166 for TribusConnect, Substantially Equivalent on 2025-03-31. Applicant: Tribusmed Beheer BV. Device class: 2.

Clearance details

Applicant: Tribusmed Beheer BV
Product code: Code QIH
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 2024-07-24
Decision date: 2025-03-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Breda, NL

Download summary PDF View on FDA.gov ↗

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