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FDA 510(k)

SM Electrodes

K-Number: K183154 · 2019-03-26

ApplicantHong Qiangxing (Shenzhen) Electronics Limited
Decision Date2019-03-26
Product CodeGXY
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

SM Electrodes is the device name listed in this FDA 510(k) record. The listed applicant is Hong Qiangxing (Shenzhen) Electronics Limited. It received FDA 510(k) clearance on 2019-03-26 under 510(k) number K183154. The device is classified under product code GXY. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SM Electrodes?

SM Electrodes is a medical device that received FDA 510(k) clearance on 2019-03-26. The listed applicant is Hong Qiangxing (Shenzhen) Electronics Limited. The 510(k) number is K183154.

When did SM Electrodes receive FDA 510(k) clearance?

SM Electrodes received FDA 510(k) clearance on 2019-03-26, under 510(k) number K183154.

Who is the listed applicant for SM Electrodes?

The FDA 510(k) record lists Hong Qiangxing (Shenzhen) Electronics Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SM Electrodes?

The FDA product code for SM Electrodes is GXY.

Other records listing Hong Qiangxing (Shenzhen) Electronics Limited as applicant

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Related Devices (Code: GXY)

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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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