The following data is part of a premarket notification filed by Excel Tech. Ltd. with the FDA for 96 Channel Eeg Headbox Model Emu96.
| Device ID | K021599 |
| 510k Number | K021599 |
| Device Name: | 96 CHANNEL EEG HEADBOX MODEL EMU96 |
| Classification | Full-montage Standard Electroencephalograph |
| Applicant | EXCEL TECH. LTD. 2568 BRISTOL CIRCLE Oakville, Ontario, CA L6h 5s1 |
| Contact | John Munford |
| Correspondent | John Munford 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 | 2002-05-15 |
| Decision Date | 2002-08-13 |
| Summary: | summary |