The following data is part of a premarket notification filed by Excel Tech. Ltd. with the FDA for Xltek Sleep System.
| Device ID | K022037 |
| 510k Number | K022037 |
| Device Name: | XLTEK SLEEP SYSTEM |
| Classification | Standard Polysomnograph With 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 | OLV |
| CFR Regulation Number | 882.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-06-24 |
| Decision Date | 2002-09-10 |
| Summary: | summary |