The following data is part of a premarket notification filed by Respironics, Inc. with the FDA for Stardust Ii.
| Device ID | K052573 |
| 510k Number | K052573 |
| Device Name: | STARDUST II |
| Classification | Ventilatory Effort Recorder |
| Applicant | RESPIRONICS, INC. 1001 MURRY RIDGE LN. Murrysville, PA 15668 |
| Contact | Zita A Yurko |
| Correspondent | Zita A Yurko RESPIRONICS, INC. 1001 MURRY RIDGE LN. Murrysville, PA 15668 |
| Product Code | MNR |
| CFR Regulation Number | 868.2375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-09-19 |
| Decision Date | 2005-12-13 |
| Summary: | summary |