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 |