The following data is part of a premarket notification filed by Daehan Medical Systems Co., Ltd. with the FDA for Dms Disposable Subdermal Needle Electrodes.
| Device ID | K161566 |
| 510k Number | K161566 |
| Device Name: | DMS Disposable Subdermal Needle Electrodes |
| Classification | Electrode, Needle |
| Applicant | Daehan Medical Systems Co., Ltd. 250 Okgucheondong-Ro Siheung City, KR 15084 |
| Contact | Dong Cheul Kim |
| Correspondent | Dong Cheul Kim Daehan Medical Systems Co., Ltd. 250 Okgucheondong-Ro Siheung City, KR 15084 |
| Product Code | GXZ |
| CFR Regulation Number | 882.1350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-06-06 |
| Decision Date | 2016-12-21 |
| Summary: | summary |