The following data is part of a premarket notification filed by Zmi Electronics, Ltd. with the FDA for Zmi Self-adhesive Electrodes.
| Device ID | K180865 |
| 510k Number | K180865 |
| Device Name: | ZMI Self-Adhesive Electrodes |
| Classification | Electrode, Cutaneous |
| Applicant | ZMI Electronics, Ltd. 6F-1, 286-4, Shin Ya Road Kaohsiung, TW 806 |
| Contact | Wayne Chen |
| Correspondent | Yuta Lee ZMI Electronics, Ltd. 6F-1, 286-4, Shin Ya Road Kaohsiung, TW 806 |
| Product Code | GXY |
| CFR Regulation Number | 882.1320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-04-02 |
| Decision Date | 2018-06-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04719872330516 | K180865 | 000 |
| 04719872330509 | K180865 | 000 |
| 04719872330431 | K180865 | 000 |
| 04719872330424 | K180865 | 000 |
| 04719872330639 | K180865 | 000 |
| 04719872330622 | K180865 | 000 |
| 04719872330929 | K180865 | 000 |