The following data is part of a premarket notification filed by Excel Tech. Ltd. with the FDA for Eeg Spike And Event Detector Module.
| Device ID | K002332 |
| 510k Number | K002332 |
| Device Name: | EEG SPIKE AND EVENT DETECTOR MODULE |
| Classification | Automatic Event Detection Software For Full-montage 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 | OMB |
| CFR Regulation Number | 882.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-08-01 |
| Decision Date | 2000-10-06 |