The following data is part of a premarket notification filed by Shenzhen Changke Connect Electronics Co., Ltd. with the FDA for Disposable Eeg Cable.
| Device ID | K213884 |
| 510k Number | K213884 |
| Device Name: | Disposable EEG Cable |
| Classification | Electrode, Cutaneous |
| Applicant | Shenzhen Changke Connect Electronics Co., Ltd. A1-2nd And A2 4th Floor Of Factory Building, No.87 Of Hengping Road, Baoan Community, Yuanshan Shenzhen, CN 518115 |
| Contact | Yahui Zhou |
| Correspondent | Kevin Wang Chonconn Medical Device Consulting Co., Ltd. Room 504, Block C, No. 1029 Nanhai Avenue, Nanshan District Shenzhen, CN 518067 |
| Product Code | GXY |
| CFR Regulation Number | 882.1320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-12-13 |
| Decision Date | 2022-05-06 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 16973874210176 | K213884 | 000 |
| 16973874210169 | K213884 | 000 |
| 16973874210152 | K213884 | 000 |
| 16973874210145 | K213884 | 000 |
| 06973874210179 | K213884 | 000 |
| 06973874210162 | K213884 | 000 |
| 06973874210155 | K213884 | 000 |
| 06973874210148 | K213884 | 000 |