The following data is part of a premarket notification filed by Excel Tech. Ltd. with the FDA for Excel Ambulatory Eeg.
| Device ID | K982479 |
| 510k Number | K982479 |
| Device Name: | EXCEL AMBULATORY EEG |
| Classification | Full-montage Standard Electroencephalograph |
| Applicant | EXCEL TECH. LTD. 2892 PORTLAND DR. Oakville,ontario, CA L6h 5w8 |
| Contact | John R Mumford |
| Correspondent | John R Mumford EXCEL TECH. LTD. 2892 PORTLAND DR. Oakville,ontario, CA L6h 5w8 |
| Product Code | GWQ |
| CFR Regulation Number | 882.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-07-16 |
| Decision Date | 1998-10-14 |