Adhesive Electrodes
K-Number: K212191 · 2021-10-06
ApplicantVoncare Medical Device Co., Ltd.
Decision Date2021-10-06
Product CodeGXY
Advisory CommitteeNE
DecisionSubstantially Equivalent
Device Summary
Adhesive Electrodes is a medical device manufactured by Voncare Medical Device Co., Ltd.. It received FDA 510(k) clearance on 2021-10-06 under approval number K212191. 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 Adhesive Electrodes?
Adhesive Electrodes is a medical device that received FDA 510(k) clearance on 2021-10-06. It is manufactured by Voncare Medical Device Co., Ltd.. The 510(k) number is K212191.
When was Adhesive Electrodes approved by the FDA?
Adhesive Electrodes received FDA 510(k) clearance on 2021-10-06, under approval number K212191.
What company makes Adhesive Electrodes?
Adhesive Electrodes is manufactured by Voncare Medical Device Co., Ltd..
What is the FDA product code for Adhesive Electrodes?
The FDA product code for Adhesive 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.