Enlight 2100 (TPL-E2103-0)— 510(k) K250464
Substantially EquivalentTimpel S.A.
FDA 510(k) clearance K250464 for Enlight 2100 (TPL-E2103-0), Substantially Equivalent on 2025-09-10. Applicant: Timpel S.A.. Device class: 2.
Clearance details
- Applicant
- Timpel S.A.
- Product code
- Code QEB
- Device class
- Class 2
- Regulation
- 21 CFR 868.1505
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- São Paulo, BR
Recent devices under product code QEB
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