TEETHAN 2.0— 510(k) K161716
Substantially EquivalentBts S.P.A.
FDA 510(k) clearance K161716 for TEETHAN 2.0, Substantially Equivalent on 2016-12-21. Applicant: Bts S.P.A.. Device class: 2.
Clearance details
- Applicant
- Bts S.P.A.
- Product code
- Code KZM
- Device class
- Class 2
- Regulation
- 21 CFR 890.1375
- Advisory panel
- Physical Medicine
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Padova, IT
Recent devices under product code KZM
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