510(k) clearance
Ultima System (UL-800);Ultimate Face Package (UL-800-Face-Set);Ultimate Shape Extension Kit 1 (UL-800-Shape-Ext-Kit-1);Ultimate Shape Extension Kit 2 (UL-800-Shape-Ext-Kit-2)
- 510(k) number
- K260945
- Applicant
- Fit-Pro KFT (Ltd.) - DBA E-Fit
- Decision date
- Sep 27, 2026
- Date received
- Mar 23, 2026
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Unknown
- Statement or summary
- Summary
- Third party
- N
- Location
- Budapest, HU