The following data is part of a premarket notification filed by Excel Tech. Ltd. with the FDA for Emu128s, Model Ex-nw-128s.
| Device ID | K040360 |
| 510k Number | K040360 |
| Device Name: | EMU128S, MODEL EX-NW-128S |
| Classification | Full-montage Standard Electroencephalograph |
| Applicant | EXCEL TECH. LTD. 2568 BRISTOL CIRCLE RD. Oakville, Ontario, CA L6h 5s1 |
| Contact | Cameron Mahon |
| Correspondent | Cameron Mahon EXCEL TECH. LTD. 2568 BRISTOL CIRCLE RD. Oakville, Ontario, CA L6h 5s1 |
| Product Code | GWQ |
| CFR Regulation Number | 882.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-02-13 |
| Decision Date | 2004-03-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00382830019194 | K040360 | 000 |
| 00382830019187 | K040360 | 000 |
| 00382830019170 | K040360 | 000 |
| 00382830019163 | K040360 | 000 |
| 00382830003049 | K040360 | 000 |
| 00382830019224 | K040360 | 000 |
| 00382830011235 | K040360 | 000 |