The following data is part of a premarket notification filed by Airway Management, Inc. with the FDA for Tap 3, Tap 1.
| Device ID | K160239 |
| 510k Number | K160239 |
| Device Name: | TAP 3, TAP 1 |
| Classification | Sleep Appliances With Patient Monitoring |
| Applicant | Airway Management, Inc. 3418 Midcourt Road, Ste. 114 Carrollton, TX 75006 |
| Contact | Dale Siebenmorgen |
| Correspondent | Paul Dryden ProMedic, Inc. 24301 Woodsage Drive Bonita Springs, FL 34134 |
| Product Code | PLC |
| CFR Regulation Number | 872.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-02-01 |
| Decision Date | 2016-08-10 |
| Summary: | summary |