FDA 510(k)

DMS Disposable Subdermal Needle Electrodes

Número K: K161566 · 2016-12-21

RequerenteDaehan Medical Systems Co., Ltd.

Data da decisão2016-12-21

Código do produtoGXZ

Comité consultivoNE

DecisãoSubstantially Equivalent

Resumo do dispositivo

DMS Disposable Subdermal Needle Electrodes is the device name listed in this FDA 510(k) record. The listed applicant is Daehan Medical Systems Co., Ltd.. It received FDA 510(k) clearance on 2016-12-21 under 510(k) number K161566. The device is classified under product code GXZ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

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. The listed applicant is Daehan Medical Systems Co., Ltd.. The 510(k) number is K161566.

When did DMS Disposable Subdermal Needle Electrodes receive FDA 510(k) clearance?

DMS Disposable Subdermal Needle Electrodes received FDA 510(k) clearance on 2016-12-21, under 510(k) number K161566.

Who is the listed applicant for DMS Disposable Subdermal Needle Electrodes?

The FDA 510(k) record lists Daehan Medical Systems Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DMS Disposable Subdermal Needle Electrodes?

The FDA product code for DMS Disposable Subdermal Needle Electrodes is GXZ.

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Fonte oficial

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