The following data is part of a premarket notification filed by Firma Ingemarsson with the FDA for Noiselezz.
| Device ID | K160531 |
| 510k Number | K160531 |
| Device Name: | Noiselezz |
| Classification | Device, Anti-snoring |
| Applicant | FIRMA INGEMARSSON VILVORDEVEJ 61 Charlottenlund, DK 2920 |
| Contact | Natashia Ingemarsson-matzen |
| Correspondent | Poul Schmidt-andersen DANISH MEDICAL DEVICES CONSULTING APS DOKTOR MUNDTSVEJ 9B Farum, DK 3520 |
| Product Code | LRK |
| CFR Regulation Number | 872.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-02-25 |
| Decision Date | 2016-09-01 |
| Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() NOISELEZZ 87444170 5476981 Live/Registered |
Petruska, LLC 2017-05-10 |