The following data is part of a premarket notification filed by Appian Medical, Inc. with the FDA for Snoresounds.
| Device ID | K150102 |
| 510k Number | K150102 |
| Device Name: | SnoreSounds |
| Classification | Ventilatory Effort Recorder |
| Applicant | APPIAN MEDICAL, INC. 502 SCRIMSHAW WAY Sevema Park, MD 21146 |
| Contact | Michael J Thomas |
| Correspondent | Michael Righter MICHAEL S. RIGHTER PO BOX 63 Tolovana Park, OR 97145 |
| Product Code | MNR |
| CFR Regulation Number | 868.2375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-01-20 |
| Decision Date | 2015-11-05 |