The following data is part of a premarket notification filed by Excel-tech Ltd. (xltek) with the FDA for Natus Sleepworks, Model 104017.
| Device ID | K090277 |
| 510k Number | K090277 |
| Device Name: | NATUS SLEEPWORKS, MODEL 104017 |
| Classification | Automatic Event Detection Software For Polysomnograph With Electroencephalograph |
| Applicant | EXCEL-TECH LTD. (XLTEK) 2568 BRISTOL CIR. Oakville, Ontario, CA L6h 5s1 |
| Contact | Goldy Singh |
| Correspondent | Goldy Singh EXCEL-TECH LTD. (XLTEK) 2568 BRISTOL CIR. Oakville, Ontario, CA L6h 5s1 |
| Product Code | OLZ |
| CFR Regulation Number | 882.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-02-04 |
| Decision Date | 2011-04-19 |