NuEra Tight Family, EMS Model— 510(k) K201239
Substantially EquivalentBios S.R.L.
FDA 510(k) clearance K201239 for NuEra Tight Family, EMS Model, Substantially Equivalent on 2020-12-31. Applicant: Bios S.R.L.. Device class: 2.
Clearance details
- Applicant
- Bios S.R.L.
- 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
- Vimodrone, IT
Recent devices under product code NGX
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