The following data is part of a premarket notification filed by Bio Protech, Inc. with the FDA for Disposable Adhesive Surface Electrodes, Disposable/reusable Cup Electrodes.
| Device ID | K153019 |
| 510k Number | K153019 |
| Device Name: | Disposable Adhesive Surface Electrodes, Disposable/Reusable Cup Electrodes |
| Classification | Electrode, Cutaneous |
| Applicant | BIO PROTECH, INC. DONGHWA MEDICAL INSTRUMENT COMPLEX, 151-3, DONGHWAGONGDAN-RO, MUNMAK-EUP Wonju-si, KR 220-801 |
| Contact | Daniel Woo |
| Correspondent | Kevin Han BIO PROTECH USA, INC. 2601 WALNUT AVE Tustin, CA 92780 |
| Product Code | GXY |
| CFR Regulation Number | 882.1320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-10-15 |
| Decision Date | 2016-03-21 |