E-Temp
K-Number: K211101 · 2021-06-14
ApplicantEnvisiontec GmbH
Decision Date2021-06-14
Product CodeEBG
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
E-Temp is a medical device manufactured by Envisiontec GmbH. It received FDA 510(k) clearance on 2021-06-14 under approval number K211101. The device is classified under product code EBG. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the E-Temp?
E-Temp is a medical device that received FDA 510(k) clearance on 2021-06-14. It is manufactured by Envisiontec GmbH. The 510(k) number is K211101.
When was E-Temp approved by the FDA?
E-Temp received FDA 510(k) clearance on 2021-06-14, under approval number K211101.
What company makes E-Temp?
E-Temp is manufactured by Envisiontec GmbH.
What is the FDA product code for E-Temp?
The FDA product code for E-Temp is EBG.
Other Devices by Envisiontec GmbH
Related Devices (Code: EBG)
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.