Cleared Traditional

VERABAND?

K233987 · Arbor Medical Innovations, LLC · Neurology
Jun 2024
Decision
182d
Days
Class 2
Risk

About This 510(k) Submission

K233987 is an FDA 510(k) clearance for the VERABAND?, a Device, Sleep Assessment (Class II — Special Controls, product code LEL), submitted by Arbor Medical Innovations, LLC (Saline, US). The FDA issued a Cleared decision on June 17, 2024, 182 days after receiving the submission on December 18, 2023. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5050.

Submission Details

510(k) Number K233987 FDA.gov
FDA Decision Cleared SESE
Date Received December 18, 2023
Decision Date June 17, 2024
Days to Decision 182 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code LEL — Device, Sleep Assessment
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.5050