The following data is part of a premarket notification filed by Daehan Medical Systems Co., Ltd. with the FDA for Daehan Adhesive Surface Electrodes.
| Device ID | K180247 |
| 510k Number | K180247 |
| Device Name: | DAEHAN Adhesive Surface Electrodes |
| Classification | Electrode, Cutaneous |
| Applicant | Daehan Medical Systems Co., Ltd. 250 Okgucheondong-Ro Siheung City, KR 15084 |
| Contact | Da Pin Jeong |
| Correspondent | Da Pin Jeong Daehan Medical Systems Co., Ltd. 250 Okgucheondong-Ro Siheung City, KR 15084 |
| Product Code | GXY |
| CFR Regulation Number | 882.1320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-01-29 |
| Decision Date | 2018-11-01 |
| Summary: | summary |