The following data is part of a premarket notification filed by Excel Tech. Ltd. with the FDA for Xltek Led Goggles, Model Led-01.
| Device ID | K011794 |
| 510k Number | K011794 |
| Device Name: | XLTEK LED GOGGLES, MODEL LED-01 |
| Classification | Stimulator, Photic, Evoked Response |
| 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 | GWE |
| CFR Regulation Number | 882.1890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-06-08 |
| Decision Date | 2001-10-01 |
| Summary: | summary |