HEBE (NP0000763)— 510(k) K241733

Substantially Equivalent

Novasonix Technology S.L.

FDA 510(k) clearance K241733 for HEBE (NP0000763), Substantially Equivalent on 2025-04-16. Applicant: Novasonix Technology S.L.. Device class: 2.

Clearance details

Applicant: Novasonix Technology S.L.
Product code: Code PBX
Device class: Class 2
Regulation: 21 CFR 878.4400
Advisory panel: General, Plastic Surgery
Date received: 2024-06-17
Decision date: 2025-04-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Granollers, ES

Download summary PDF View on FDA.gov ↗

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