Enlight 2100
K-Number: K211135 · 2022-01-06
ApplicantTimpel S.A.
Decision Date2022-01-06
Product CodeQEB
Advisory CommitteeAN
DecisionSubstantially Equivalent
Device Summary
Enlight 2100 is a medical device manufactured by Timpel S.A.. It received FDA 510(k) clearance on 2022-01-06 under approval number K211135. The device is classified under product code QEB. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Enlight 2100?
Enlight 2100 is a medical device that received FDA 510(k) clearance on 2022-01-06. It is manufactured by Timpel S.A.. The 510(k) number is K211135.
When was Enlight 2100 approved by the FDA?
Enlight 2100 received FDA 510(k) clearance on 2022-01-06, under approval number K211135.
What company makes Enlight 2100?
Enlight 2100 is manufactured by Timpel S.A..
What is the FDA product code for Enlight 2100?
The FDA product code for Enlight 2100 is QEB.
Other Devices by Timpel S.A.
Related Devices (Code: QEB)
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.