The following data is part of a premarket notification filed by Resmed Sas with the FDA for Narval Brux.
| Device ID | K143623 |
| 510k Number | K143623 |
| Device Name: | Narval Brux |
| Classification | Mouthguard, Prescription |
| Applicant | RESMED SAS 292, ALLEE JACQUES, MONOD Saint-priest Cedex, FR 69791 |
| Contact | Larissa D'andrea |
| Correspondent | Allison C Komiyama RESMED CORP. 9001 SPECTRUM CENTER BOULEVARD San Diego, CA 92123 |
| Product Code | MQC |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-12-22 |
| Decision Date | 2015-08-13 |
| Summary: | summary |