E-Fit Infinity System (EF-2090 Controller and EF-100 Unit)— 510(k) K202148
Substantially EquivalentFit-Pro , Ltd.
FDA 510(k) clearance K202148 for E-Fit Infinity System (EF-2090 Controller and EF-100 Unit), Substantially Equivalent on 2021-08-25. Applicant: Fit-Pro , Ltd.. Device class: 2.
Clearance details
- Applicant
- Fit-Pro , Ltd.
- Product code
- Code NGX
- Device class
- Class 2
- Regulation
- 21 CFR 890.5850
- Advisory panel
- Physical Medicine
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Budapest, HU
Recent devices under product code NGX
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