The following data is part of a premarket notification filed by Daehan Medical Systems Co., Ltd. with the FDA for Daehan Disposable Cup Electrodes.
| Device ID | K180232 |
| 510k Number | K180232 |
| Device Name: | DAEHAN Disposable CUP Electrodes |
| Classification | Electrode, Cutaneous |
| Applicant | Daehan Medical Systems Co., Ltd. 250 Okgucheondong-Ro Siheung-city, KR 15084 |
| Contact | Da Roo Ha |
| Correspondent | Da Roo Ha 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 | 2019-04-03 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08800036901829 | K180232 | 000 |