Disposable Adhesive Surface Electrodes, Disposable/Reusable Cup Electrodes
FDA 510(k) K153019 · Bio Protech, Inc.
510(k) numberK153019
Submission
- Device name
- Disposable Adhesive Surface Electrodes, Disposable/Reusable Cup Electrodes
- Applicant
- Bio Protech, Inc.
Wonju-Si, KR - Received
- October 15, 2015
- Decision date
- March 21, 2016
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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Questions and answers
When was Disposable Adhesive Surface Electrodes, Disposable/Reusable Cup Electrodes cleared by the FDA?
Disposable Adhesive Surface Electrodes, Disposable/Reusable Cup Electrodes (K153019) received a 510(k) decision of Substantially Equivalent on March 21, 2016, 158 days after the submission was received.
What is the product code of K153019?
The FDA product code is GXY – Electrode, Cutaneous, a Class II (moderate risk) device regulated under 21 CFR 882.1320.