The following data is part of a premarket notification filed by Sleep Medicine Network, Inc. with the FDA for Sleep App.
| Device ID | K100185 |
| 510k Number | K100185 |
| Device Name: | SLEEP APP |
| Classification | Device, Anti-snoring |
| Applicant | SLEEP MEDICINE NETWORK, INC. 7931 NE HALSEY SUITE 305 Portland, OR 97213 |
| Contact | Richard Moore |
| Correspondent | Richard Moore SLEEP MEDICINE NETWORK, INC. 7931 NE HALSEY SUITE 305 Portland, OR 97213 |
| Product Code | LRK |
| CFR Regulation Number | 872.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-01-22 |
| Decision Date | 2010-11-19 |