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FDA 510(k)

HybridTherm System

K-Number: K240932 · 2024-08-05

ApplicantErbe Elektromedizin GmbH
Decision Date2024-08-05
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

HybridTherm System is a medical device manufactured by Erbe Elektromedizin GmbH. It received FDA 510(k) clearance on 2024-08-05 under approval number K240932. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HybridTherm System?

HybridTherm System is a medical device that received FDA 510(k) clearance on 2024-08-05. It is manufactured by Erbe Elektromedizin GmbH. The 510(k) number is K240932.

When was HybridTherm System approved by the FDA?

HybridTherm System received FDA 510(k) clearance on 2024-08-05, under approval number K240932.

What company makes HybridTherm System?

HybridTherm System is manufactured by Erbe Elektromedizin GmbH.

What is the FDA product code for HybridTherm System?

The FDA product code for HybridTherm System is GEI.

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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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