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FDA 510(k)

Thermeo System

K-Number: K212017 · 2022-04-08

ApplicantPro3Dure Medical GmbH
Decision Date2022-04-08
Product CodeMQC
DecisionSubstantially Equivalent

Device Summary

Thermeo System is a medical device manufactured by Pro3Dure Medical GmbH. It received FDA 510(k) clearance on 2022-04-08 under approval number K212017. The device is classified under product code MQC. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Thermeo System?

Thermeo System is a medical device that received FDA 510(k) clearance on 2022-04-08. It is manufactured by Pro3Dure Medical GmbH. The 510(k) number is K212017.

When was Thermeo System approved by the FDA?

Thermeo System received FDA 510(k) clearance on 2022-04-08, under approval number K212017.

What company makes Thermeo System?

Thermeo System is manufactured by Pro3Dure Medical GmbH.

What is the FDA product code for Thermeo System?

The FDA product code for Thermeo System is MQC.

Other Devices by Pro3Dure Medical GmbH

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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.

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