The following data is part of a premarket notification filed by Excel Tech. Ltd. with the FDA for Eeg Real Patient Spike And Event Detector Module, Model Ex-sp-rp (proposed).
| Device ID | K010085 |
| 510k Number | K010085 |
| Device Name: | EEG REAL PATIENT SPIKE AND EVENT DETECTOR MODULE, MODEL EX-SP-RP (PROPOSED) |
| Classification | Automatic Event Detection Software For Full-montage Electroencephalograph |
| Applicant | EXCEL TECH. LTD. 2568 BRISTOL CIRCLE Oakville, Ontario, CA L6h 5s1 |
| Contact | Sonja Markez |
| Correspondent | Sonja Markez 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 | 2001-01-11 |
| Decision Date | 2001-03-15 |