The following data is part of a premarket notification filed by Dong Guan Ou Kang Electronics Co., Ltd with the FDA for Self-adhesive Electrode.
| Device ID | K181234 |
| 510k Number | K181234 |
| Device Name: | Self-adhesive Electrode |
| Classification | Electrode, Cutaneous |
| Applicant | Dong Guan Ou Kang Electronics CO., LTD 3rd Floor, Xiqunli Building, Shipai Road, Yanwo Village Shipai Town Dongguan, CN 523407 |
| Contact | Nianjun Liu |
| Correspondent | Field Fu Shenzhen Joyantech Consulting Co., Ltd. Room 1122, International Mayors Communication Centre Shenzhen, CN 511470 |
| Product Code | GXY |
| CFR Regulation Number | 882.1320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-05-09 |
| Decision Date | 2018-08-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06976378040044 | K181234 | 000 |
| 06976378040037 | K181234 | 000 |
| 06976378040020 | K181234 | 000 |
| 06976378040013 | K181234 | 000 |
| 06976378040006 | K181234 | 000 |