FDA 510(k)

E-Temp

K-Number: K211101 · 2021-06-14

Decision Date2021-06-14

Product CodeEBG

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

E-Temp is the device name listed in this FDA 510(k) record. The listed applicant is Envisiontec GmbH. It received FDA 510(k) clearance on 2021-06-14 under 510(k) 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. The listed applicant is Envisiontec GmbH. The 510(k) number is K211101.

When did E-Temp receive FDA 510(k) clearance?

E-Temp received FDA 510(k) clearance on 2021-06-14, under 510(k) number K211101.

Who is the listed applicant for E-Temp?

The FDA 510(k) record lists Envisiontec GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for E-Temp?

The FDA product code for E-Temp is EBG.

Other records listing Envisiontec GmbH as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.