Narval Brux
FDA 510(k) K143623 · Resmed Sas
510(k) numberK143623
Submission
- Device name
- Narval Brux
- Applicant
- Resmed Sas
Saint-Priest Cedex, FR - Received
- December 22, 2014
- Decision date
- August 13, 2015
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MQC – Mouthguard, Prescription
- Device class
- Unclassified
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Questions and answers
When was Narval Brux cleared by the FDA?
Narval Brux (K143623) received a 510(k) decision of Substantially Equivalent on August 13, 2015, 234 days after the submission was received.
What is the product code of K143623?
The FDA product code is MQC – Mouthguard, Prescription, a Unclassified device.