The following data is part of a premarket notification filed by Respironics, Inc. with the FDA for Remview Sleep Recorder, Model 320.
| Device ID | K003499 |
| 510k Number | K003499 |
| Device Name: | REMVIEW SLEEP RECORDER, MODEL 320 |
| Classification | Device, Sleep Assessment |
| Applicant | RESPIRONICS, INC. 1001 MURRY RIDGE LN. Murrysville, PA 15668 |
| Contact | David J Vanella |
| Correspondent | David J Vanella RESPIRONICS, INC. 1001 MURRY RIDGE LN. Murrysville, PA 15668 |
| Product Code | LEL |
| CFR Regulation Number | 882.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-11-13 |
| Decision Date | 2001-02-09 |