The following data is part of a premarket notification filed by Excel Tech. Ltd. with the FDA for Excel Photic Stimulator, Model (xlps-1).
| Device ID | K991903 |
| 510k Number | K991903 |
| Device Name: | EXCEL PHOTIC STIMULATOR, MODEL (XLPS-1) |
| Classification | Stimulator, Photic, Evoked Response |
| 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 | GWE |
| CFR Regulation Number | 882.1890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-06-04 |
| Decision Date | 1999-08-04 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00382830043397 | K991903 | 000 |
| 00382830019101 | K991903 | 000 |
| 00382830015950 | K991903 | 000 |
| 00382830015790 | K991903 | 000 |