Cleared Traditional

NomadAir PMU810

K220631 · Neurotronics, Inc. · Neurology
Jul 2022
Decision
133d
Days
Class 2
Risk

About This 510(k) Submission

K220631 is an FDA 510(k) clearance for the NomadAir PMU810, a Amplifier, Physiological Signal (Class II — Special Controls, product code GWL), submitted by Neurotronics, Inc. (Gainesville, US). The FDA issued a Cleared decision on July 15, 2022, 133 days after receiving the submission on March 4, 2022. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1835.

Submission Details

510(k) Number K220631 FDA.gov
FDA Decision Cleared SESE
Date Received March 04, 2022
Decision Date July 15, 2022
Days to Decision 133 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