The following data is part of a premarket notification filed by Shaoxing Dl Healthcare Co., Ltd. with the FDA for Dl Self-adhesive Electrode.
| Device ID | K182111 |
| 510k Number | K182111 |
| Device Name: | DL Self-adhesive Electrode |
| Classification | Electrode, Cutaneous |
| Applicant | Shaoxing DL Healthcare Co., Ltd. Jiulin Land, Baiguan Street, Shangyu District Shaoxing, CN 312300 |
| Contact | Zhao Qingya |
| Correspondent | Doris Dong Shanghai CV Technology Co., Ltd Room 903, No. 19 Dongbao Road, Songjiang Area Shanghai, CN 201613 |
| Product Code | GXY |
| CFR Regulation Number | 882.1320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-08-06 |
| Decision Date | 2019-01-17 |
| Summary: | summary |