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FDA 510(k)

ThermiX Temperature Control Radiofrequency System, Accessories - RF Electrodes

K-Number: K173582 · 2018-01-17

ApplicantThermigen, L.L.C
Decision Date2018-01-17
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ThermiX Temperature Control Radiofrequency System, Accessories - RF Electrodes is a medical device manufactured by Thermigen, L.L.C. It received FDA 510(k) clearance on 2018-01-17 under approval number K173582. 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 ThermiX Temperature Control Radiofrequency System, Accessories - RF Electrodes?

ThermiX Temperature Control Radiofrequency System, Accessories - RF Electrodes is a medical device that received FDA 510(k) clearance on 2018-01-17. It is manufactured by Thermigen, L.L.C. The 510(k) number is K173582.

When was ThermiX Temperature Control Radiofrequency System, Accessories - RF Electrodes approved by the FDA?

ThermiX Temperature Control Radiofrequency System, Accessories - RF Electrodes received FDA 510(k) clearance on 2018-01-17, under approval number K173582.

What company makes ThermiX Temperature Control Radiofrequency System, Accessories - RF Electrodes?

ThermiX Temperature Control Radiofrequency System, Accessories - RF Electrodes is manufactured by Thermigen, L.L.C.

What is the FDA product code for ThermiX Temperature Control Radiofrequency System, Accessories - RF Electrodes?

The FDA product code for ThermiX Temperature Control Radiofrequency System, Accessories - RF Electrodes is GEI.

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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.

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