The following data is part of a premarket notification filed by Excel Tech. Ltd. with the FDA for 128 Channel Eeg Headbox, Model Ex-nw-128.
| Device ID | K000919 |
| 510k Number | K000919 |
| Device Name: | 128 CHANNEL EEG HEADBOX, MODEL EX-NW-128 |
| Classification | Full-montage Standard Electroencephalograph |
| Applicant | EXCEL TECH. LTD. 2568 BRISTOL CIRCLE Oakville, Ontario, CA L6h 5s1 |
| Contact | Debbie Davy |
| Correspondent | Debbie Davy EXCEL TECH. LTD. 2568 BRISTOL CIRCLE Oakville, Ontario, CA L6h 5s1 |
| Product Code | GWQ |
| CFR Regulation Number | 882.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-03-22 |
| Decision Date | 2000-08-31 |