DL Self-adhesive Electrode
K-Number: K182111 · 2019-01-17
ApplicantShaoxing DL Healthcare Co., Ltd.
Decision Date2019-01-17
Product CodeGXY
Advisory CommitteeNE
DecisionSubstantially Equivalent
Device Summary
DL Self-adhesive Electrode is a medical device manufactured by Shaoxing DL Healthcare Co., Ltd.. It received FDA 510(k) clearance on 2019-01-17 under approval number K182111. 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 DL Self-adhesive Electrode?
DL Self-adhesive Electrode is a medical device that received FDA 510(k) clearance on 2019-01-17. It is manufactured by Shaoxing DL Healthcare Co., Ltd.. The 510(k) number is K182111.
When was DL Self-adhesive Electrode approved by the FDA?
DL Self-adhesive Electrode received FDA 510(k) clearance on 2019-01-17, under approval number K182111.
What company makes DL Self-adhesive Electrode?
DL Self-adhesive Electrode is manufactured by Shaoxing DL Healthcare Co., Ltd..
What is the FDA product code for DL Self-adhesive Electrode?
The FDA product code for DL Self-adhesive Electrode 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.