K232735

EMA 3D

510(k) number
K232735
Device name
EMA 3D
Applicant
Ema Sleep Incorporated TX · US
Product code
LRK — Device, Anti-Snoring
Decision date
2024-05-03
Date received
2023-09-07
Decision
Substantially Equivalent
Clearance type
Traditional
Advisory committee
Dental
PDFDownload 510(k) SummaryArchived here · 1.0 MB · U.S. public domain

Also available from FDA: K232735.pdf

Official FDA record: K232735
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.