The following data is part of a premarket notification filed by Conmed Corporation with the FDA for Brainstream Disposable Deep Cup Eeg Electrodes.
| Device ID | K200540 |
| 510k Number | K200540 |
| Device Name: | BRAINSTREAM Disposable Deep Cup EEG Electrodes |
| Classification | Electrode, Cutaneous |
| Applicant | CONMED Corporation 525 French Road Utica, NY 13502 |
| Contact | Tessa Hopsicker |
| Correspondent | Tessa Hopsicker CONMED Corporation 525 French Road Utica, NY 13502 |
| Product Code | GXY |
| CFR Regulation Number | 882.1320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-03-03 |
| Decision Date | 2020-06-01 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30653405986663 | K200540 | 000 |
| 30653405987066 | K200540 | 000 |
| 30653405987073 | K200540 | 000 |
| 30653405987080 | K200540 | 000 |
| 30653405987097 | K200540 | 000 |
| 30653405987103 | K200540 | 000 |
| 30653405987110 | K200540 | 000 |
| 30653405987127 | K200540 | 000 |
| 30653405987134 | K200540 | 000 |
| 30653405986649 | K200540 | 000 |
| 30653405986656 | K200540 | 000 |
| 30653405987059 | K200540 | 000 |