FDA 510(k)

ELRA Electrode

K-Number: K181758 · 2019-04-11

Decision Date2019-04-11

Product CodeKNS

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

ELRA Electrode is a medical device manufactured by Starmed Co., Ltd.. It received FDA 510(k) clearance on 2019-04-11 under approval number K181758. The device is classified under product code KNS. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ELRA Electrode?

ELRA Electrode is a medical device that received FDA 510(k) clearance on 2019-04-11. It is manufactured by Starmed Co., Ltd.. The 510(k) number is K181758.

When was ELRA Electrode approved by the FDA?

ELRA Electrode received FDA 510(k) clearance on 2019-04-11, under approval number K181758.

What company makes ELRA Electrode?

ELRA Electrode is manufactured by Starmed Co., Ltd..

What is the FDA product code for ELRA Electrode?

The FDA product code for ELRA Electrode is KNS.

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.