Cleared Special

Digital NeuroPort Biopotential Signal Processing System

K202174 · Blackrock Microsystems · Neurology
Feb 2021
Decision
190d
Days
Class 2
Risk

About This 510(k) Submission

K202174 is an FDA 510(k) clearance for the Digital NeuroPort Biopotential Signal Processing System, a Amplifier, Physiological Signal (Class II — Special Controls, product code GWL), submitted by Blackrock Microsystems (Salt Lake City, US). The FDA issued a Cleared decision on February 10, 2021, 190 days after receiving the submission on August 4, 2020. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1835.

Submission Details

510(k) Number K202174 FDA.gov
FDA Decision Cleared SESE
Date Received August 04, 2020
Decision Date February 10, 2021
Days to Decision 190 days
Submission Type Special
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