The following data is part of a premarket notification filed by Moses Appliances Llc with the FDA for Express 4 Sleep Appliance/cpap Sidekick Appliance.
Device ID | K173856 |
510k Number | K173856 |
Device Name: | Express 4 Sleep Appliance/CPAP Sidekick Appliance |
Classification | Device, Anti-snoring |
Applicant | Moses Appliances LLC 75-768 Valle Vista Drive Indian Wells, CA 92210 |
Contact | Allen J. Moses |
Correspondent | Allen J. Moses Moses Appliances LLC 75-768 Valle Vista Drive Indian Wells, CA 92210 |
Product Code | LRK |
CFR Regulation Number | 872.5570 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2017-12-20 |
Decision Date | 2018-06-26 |