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

K233987

VERABAND™

510(k) number
K233987
Device name
VERABAND™
Applicant
Arbor Medical Innovations, LLC MI · US
Product code
LEL — Device, Sleep Assessment
Decision date
2024-06-17
Date received
2023-12-18
Decision
Substantially Equivalent
Clearance type
Traditional
Advisory committee
Neurology
PDFDownload 510(k) SummaryArchived here · 4.5 MB · U.S. public domain

Also available from FDA: K233987.pdf

Official FDA record: K233987
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.