The following data is part of a premarket notification filed by Orthoapnea S.l. with the FDA for Noa Sleep Apnea And Snoring Device.
| Device ID | K202651 |
| 510k Number | K202651 |
| Device Name: | NOA Sleep Apnea And Snoring Device |
| Classification | Device, Anti-snoring |
| Applicant | Orthoapnea S.L. C / Flauta Magica 22 Malaga, ES 29006 |
| Contact | Jose Repolles Llecha |
| Correspondent | Jose Repolles Llecha Orthoapnea S.L. C / Flauta Magica 22 Malaga, ES 29006 |
| Product Code | LRK |
| CFR Regulation Number | 872.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-09-14 |
| Decision Date | 2021-02-12 |