PreOp v3— 510(k) K252565

Substantially Equivalent

Clouds of Care

FDA 510(k) clearance K252565 for PreOp v3, Substantially Equivalent on 2026-02-13. Applicant: Clouds of Care. Device class: 2.

Clearance details

Applicant: Clouds of Care
Product code: Code OLX
Device class: Class 2
Regulation: 21 CFR 882.1400
Advisory panel: Neurology
Date received: 2025-08-14
Decision date: 2026-02-13
Decision: Substantially Equivalent
Clearance type: Special
Location: Ghent, BE

Download summary PDF View on FDA.gov ↗

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