DMS Disposable Subdermal Needle Electrodes
K-Number: K161566 · 2016-12-21
ApplicantDaehan Medical Systems Co., Ltd.
Decision Date2016-12-21
Product CodeGXZ
Advisory CommitteeNE
DecisionSubstantially Equivalent
Device Summary
DMS Disposable Subdermal Needle Electrodes is a medical device manufactured by Daehan Medical Systems Co., Ltd.. It received FDA 510(k) clearance on 2016-12-21 under approval number K161566. The device is classified under product code GXZ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the DMS Disposable Subdermal Needle Electrodes?
DMS Disposable Subdermal Needle Electrodes is a medical device that received FDA 510(k) clearance on 2016-12-21. It is manufactured by Daehan Medical Systems Co., Ltd.. The 510(k) number is K161566.
When was DMS Disposable Subdermal Needle Electrodes approved by the FDA?
DMS Disposable Subdermal Needle Electrodes received FDA 510(k) clearance on 2016-12-21, under approval number K161566.
What company makes DMS Disposable Subdermal Needle Electrodes?
DMS Disposable Subdermal Needle Electrodes is manufactured by Daehan Medical Systems Co., Ltd..
What is the FDA product code for DMS Disposable Subdermal Needle Electrodes?
The FDA product code for DMS Disposable Subdermal Needle Electrodes is GXZ.
Related Clinical Trials
Other Devices by Daehan Medical Systems Co., Ltd.
Related Devices (Code: GXZ)
K192603Spes Medica Subdermal Needle ElectrodesSpes Medica Srl
K190801PressOn Electrode HeadsetRhythmlink International, LLC
K200984Guardian Needle ElectrodeRhythmlink International, LLC
K232581Medical Disposable Sterile Needle ElectrodeSuzhou Haishen Medical Device Associates Co., Ltd.
K231691Phantom XL Insulated DilatorsTeDan Surgical Innovations, Inc.
K241045Disposable Subdermal Needle Electrode, CorkscrewTechnomed Europe
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.