The following data is part of a premarket notification filed by Wuhan Greentek Pty Ltd. with the FDA for Disposable Eeg Electrodes (model: Dl, E-cap, Flex-cap).
| Device ID | K200162 |
| 510k Number | K200162 |
| Device Name: | Disposable EEG Electrodes (MODEL: DL, E-CAP, FLEX-CAP) |
| Classification | Electrode, Cutaneous |
| Applicant | Wuhan Greentek Pty Ltd. Rm 03-2, Flr. 3, Dingye Bldg, Phase III Intl Enterprise Ctr. Special No.1 Guanggu Ave Donghu New Technology Dev. Zone Wuhan, CN 430074 |
| Contact | Yarong Liu |
| Correspondent | Yarong Liu Wuhan Greentek Pty Ltd. Rm 03-2, Flr. 3, Dingye Bldg, Phase III Intl Enterprise Ctr. Special No.1 Guanggu Ave Donghu New Technology Dev. Zone Wuhan, CN 430074 |
| Product Code | GXY |
| CFR Regulation Number | 882.1320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-01-22 |
| Decision Date | 2020-04-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06970295340003 | K200162 | 000 |
| 06970295340041 | K200162 | 000 |
| 06970295340652 | K200162 | 000 |