510(k) K233987

VERABAND™ by Arbor Medical Innovations, LLC — Product Code LEL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 17, 2024
Date Received
December 18, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Sleep Assessment
Device Class
Class II
Regulation Number
882.5050
Review Panel
NE
Submission Type