Cleared Traditional

Vlab

K230148 · Dormotech Medical, Ltd. · Neurology
Oct 2023
Decision
265d
Days
Class 2
Risk

About This 510(k) Submission

K230148 is an FDA 510(k) clearance for the Vlab, a Amplifier, Physiological Signal (Class II — Special Controls, product code GWL), submitted by Dormotech Medical, Ltd. (Afula, IL). The FDA issued a Cleared decision on October 11, 2023, 265 days after receiving the submission on January 19, 2023. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1835.

Submission Details

510(k) Number K230148 FDA.gov
FDA Decision Cleared SESE
Date Received January 19, 2023
Decision Date October 11, 2023
Days to Decision 265 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code GWL — Amplifier, Physiological Signal
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.1835