Disposable Adhesive Surface Electrodes, Disposable/Reusable Cup Electrodes— 510(k) K153019
Substantially EquivalentBio Protech, Inc.
FDA 510(k) clearance K153019 for Disposable Adhesive Surface Electrodes, Disposable/Reusable Cup Electrodes, Substantially Equivalent on 2016-03-21. Applicant: Bio Protech, Inc.. Device class: 2.
Clearance details
- Applicant
- Bio Protech, Inc.
- Product code
- Code GXY
- Device class
- Class 2
- Regulation
- 21 CFR 882.1320
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Wonju-Si, KR
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