Mr. Gan · haixiao@sungolytest.com · +86 158 2169 5110 · +86 132 4819 8029Mr. Luo · jun.luo@sungoglobal.com · +86 177 5560 4650

K240427

airVata™

510(k) number
K240427
Device name
airVata™
Applicant
Gelb Practice Solutions, Inc. NY · US
Product code
LRK — Device, Anti-Snoring
Decision date
2024-02-14
Date received
2024-02-13
Decision
Substantially Equivalent
Clearance type
Traditional
Flag
Third-party review
Advisory committee
Dental
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain

Also available from FDA: K240427.pdf

Official FDA record: K240427
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.