FDA 510(k)

EUSRA RF Electrode

K-Number: K181249 · 2018-09-04

Decision Date2018-09-04

Product CodeGEI

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

EUSRA RF Electrode is a medical device manufactured by Starmed Co., Ltd.. It received FDA 510(k) clearance on 2018-09-04 under approval number K181249. 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 EUSRA RF Electrode?

EUSRA RF Electrode is a medical device that received FDA 510(k) clearance on 2018-09-04. It is manufactured by Starmed Co., Ltd.. The 510(k) number is K181249.

When was EUSRA RF Electrode approved by the FDA?

EUSRA RF Electrode received FDA 510(k) clearance on 2018-09-04, under approval number K181249.

What company makes EUSRA RF Electrode?

EUSRA RF Electrode is manufactured by Starmed Co., Ltd..

What is the FDA product code for EUSRA RF Electrode?

The FDA product code for EUSRA RF Electrode is GEI.

Other Devices by Starmed Co., Ltd.

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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.