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 |