FISIOWARM 7.0— 510(k) K232966

Substantially Equivalent

Golden Star Srl

FDA 510(k) clearance K232966 for FISIOWARM 7.0, Substantially Equivalent on 2024-12-26. Applicant: Golden Star Srl. Device class: 2.

Clearance details

Applicant: Golden Star Srl
Product code: Code PBX
Device class: Class 2
Regulation: 21 CFR 878.4400
Advisory panel: General, Plastic Surgery
Date received: 2023-09-21
Decision date: 2024-12-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Roma, IT

Download summary PDF View on FDA.gov ↗

Recent devices under product code PBX

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