The following data is part of a premarket notification filed by Excel Tech. Ltd. with the FDA for Xltek Polysomnography Headbox, Model # Psg-40.
| Device ID | K991900 |
| 510k Number | K991900 |
| Device Name: | XLTEK POLYSOMNOGRAPHY HEADBOX, MODEL # PSG-40 |
| Classification | Standard Polysomnograph With Electroencephalograph |
| Applicant | EXCEL TECH. LTD. 2892 PORTLAND DR. Oakville,ontario, CA L6h 5w8 |
| Contact | Mark T Zajac |
| Correspondent | Mark T Zajac EXCEL TECH. LTD. 2892 PORTLAND DR. Oakville,ontario, CA L6h 5w8 |
| Product Code | OLV |
| CFR Regulation Number | 882.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-06-04 |
| Decision Date | 1999-07-12 |