StarFormer— 510(k) K234061
Substantially EquivalentFotona D.O.O.
FDA 510(k) clearance K234061 for StarFormer, Substantially Equivalent on 2024-07-01. Applicant: Fotona D.O.O.. Device class: 2.
Clearance details
- Applicant
- Fotona D.O.O.
- Product code
- Code KPI
- Device class
- Class 2
- Regulation
- 21 CFR 876.5320
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Ljubljana, SI
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More clearances from Fotona D.O.O.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.