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FDA 510(k)

Thermi Reusable Non-invasive RF Electrode

K-Number: K171094 · 2017-05-08

ApplicantThermgen, L.L.C
Decision Date2017-05-08
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Thermi Reusable Non-invasive RF Electrode is a medical device manufactured by Thermgen, L.L.C. It received FDA 510(k) clearance on 2017-05-08 under approval number K171094. 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 Thermi Reusable Non-invasive RF Electrode?

Thermi Reusable Non-invasive RF Electrode is a medical device that received FDA 510(k) clearance on 2017-05-08. It is manufactured by Thermgen, L.L.C. The 510(k) number is K171094.

When was Thermi Reusable Non-invasive RF Electrode approved by the FDA?

Thermi Reusable Non-invasive RF Electrode received FDA 510(k) clearance on 2017-05-08, under approval number K171094.

What company makes Thermi Reusable Non-invasive RF Electrode?

Thermi Reusable Non-invasive RF Electrode is manufactured by Thermgen, L.L.C.

What is the FDA product code for Thermi Reusable Non-invasive RF Electrode?

The FDA product code for Thermi Reusable Non-invasive RF Electrode is GEI.

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Official Source

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