The following data is part of a premarket notification filed by Dynadx Corporation with the FDA for Sleep Quality.
| Device ID | K070855 |
| 510k Number | K070855 |
| Device Name: | SLEEP QUALITY |
| Classification | Ventilatory Effort Recorder |
| Applicant | DYNADX CORPORATION 1676 VILLAGE GREEN STE. A Crofton, MD 21114 |
| Contact | Ej Smith |
| Correspondent | Ej Smith DYNADX CORPORATION 1676 VILLAGE GREEN STE. A Crofton, MD 21114 |
| Product Code | MNR |
| CFR Regulation Number | 868.2375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-03-28 |
| Decision Date | 2008-03-20 |
| Summary: | summary |