The following data is part of a premarket notification filed by Respironics, Inc. with the FDA for Sleepware G3.
| Device ID | K142988 |
| 510k Number | K142988 |
| Device Name: | Sleepware G3 |
| Classification | Automatic Event Detection Software For Polysomnograph With Electroencephalograph |
| Applicant | RESPIRONICS, INC. 1001 MURRY RIDGE LANE Murrysville, PA 15668 |
| Contact | Daniela Aizpitarte |
| Correspondent | Daniela Aizpitarte RESPIRONICS, INC. 1740 GOLDEN MILE HIGHWAY Monroeville, PA 15146 |
| Product Code | OLZ |
| Subsequent Product Code | MNR |
| Subsequent Product Code | OLV |
| CFR Regulation Number | 882.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-10-16 |
| Decision Date | 2015-03-16 |
| Summary: | summary |