DAEHAN Adhesive Surface Electrodes

FDA 510(k) K180247 · Daehan Medical Systems Co., Ltd.

Substantially Equivalent

510(k) numberK180247

Submission

Device name
DAEHAN Adhesive Surface Electrodes
Applicant
Daehan Medical Systems Co., Ltd.
Siheung-City, KR
Received
January 29, 2018
Decision date
November 1, 2018
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
GXY – Electrode, Cutaneous
Device class
Class II (moderate risk)
Regulation
21 CFR 882.1320
Specialty
Neurology

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Questions and answers

When was DAEHAN Adhesive Surface Electrodes cleared by the FDA?

DAEHAN Adhesive Surface Electrodes (K180247) received a 510(k) decision of Substantially Equivalent on November 1, 2018, 276 days after the submission was received.

What is the product code of K180247?

The FDA product code is GXY – Electrode, Cutaneous, a Class II (moderate risk) device regulated under 21 CFR 882.1320.