Enlight 2100 (TPL-E2103-0)— 510(k) K250464

Substantially Equivalent

Timpel S.A.

FDA 510(k) clearance K250464 for Enlight 2100 (TPL-E2103-0), Substantially Equivalent on 2025-09-10. Applicant: Timpel S.A..

Clearance details

Applicant: Timpel S.A.
Product code: Code QEB
Advisory panel: Anesthesiology
Date received: 2025-02-18
Decision date: 2025-09-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: São Paulo, BR

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