The following data is part of a premarket notification filed by Excel Tech. Ltd. with the FDA for Wireless Ambulatory Eeg, Model Ex-amb-wireless (proposed).
| Device ID | K001103 |
| 510k Number | K001103 |
| Device Name: | WIRELESS AMBULATORY EEG, MODEL EX-AMB-WIRELESS (PROPOSED) |
| Classification | Full-montage Standard 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 | GWQ |
| CFR Regulation Number | 882.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-04-05 |
| Decision Date | 2000-06-30 |