Decision Date2019-03-26
Product CodeGXY
Advisory CommitteeNE
DecisionSubstantially Equivalent
Device Summary
SM Electrodes is a medical device manufactured by Hong Qiangxing (Shenzhen) Electronics Limited. It received FDA 510(k) clearance on 2019-03-26 under approval 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. It is manufactured by Hong Qiangxing (Shenzhen) Electronics Limited. The 510(k) number is K183154.
When was SM Electrodes approved by the FDA?
SM Electrodes received FDA 510(k) clearance on 2019-03-26, under approval number K183154.
What company makes SM Electrodes?
SM Electrodes is manufactured by Hong Qiangxing (Shenzhen) Electronics Limited.
What is the FDA product code for SM Electrodes?
The FDA product code for SM Electrodes is 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.