The following data is part of a premarket notification filed by Respironics, Inc. with the FDA for Sleepware G3.
| Device ID | K202142 |
| 510k Number | K202142 |
| Device Name: | Sleepware G3 |
| Classification | Automatic Event Detection Software For Polysomnograph With Electroencephalograph |
| Applicant | Respironics, Inc. 1001 Murry Ridge Lane Murrysville, PA 15668 |
| Contact | Jonquil Mau |
| Correspondent | Jonquil Mau Respironics, Inc. 1001 Murry Ridge Lane Murrysville, PA 15668 |
| Product Code | OLZ |
| CFR Regulation Number | 882.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-07-31 |
| Decision Date | 2020-10-29 |