Enlight 2100— 510(k) K211135

Substantially Equivalent

Timpel S.A.

FDA 510(k) clearance K211135 for Enlight 2100, Substantially Equivalent on 2022-01-06. 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: 2021-04-16
Decision date: 2022-01-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sao Paulo, BR

Download summary PDF View on FDA.gov ↗

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DEN170072 — Enlight 18102018-12-20

Data sourced from openFDA. This site is unofficial and independent of the FDA.