The following data is part of a premarket notification filed by Excel Tech. Ltd. with the FDA for Excel Neuro Works.
| Device ID | K980214 |
| 510k Number | K980214 |
| Device Name: | EXCEL NEURO WORKS |
| 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 | 1998-01-21 |
| Decision Date | 1998-04-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00382830003001 | K980214 | 000 |
| 00382830047425 | K980214 | 000 |