Digital NeuroPort Biopotential Signal Processing System— 510(k) K202174

Name: FDA 510(k) clearance K202174
Creator: U.S. Food and Drug Administration
Published: 2021-02-10

Substantially Equivalent

Blackrock Microsystems

FDA 510(k) clearance K202174 for Digital NeuroPort Biopotential Signal Processing System, Substantially Equivalent on 2021-02-10. Applicant: Blackrock Microsystems. Device class: 2.

Clearance details

Applicant: Blackrock Microsystems
Product code: Code GWL
Device class: Class 2
Regulation: 21 CFR 882.1835
Advisory panel: Neurology
Date received: 2020-08-04
Decision date: 2021-02-10
Decision: Substantially Equivalent
Clearance type: Special
Location: Salt Lake City, UT, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code GWL

view all

K243746 — Delphi Amplifier2025-03-12
K242832 — NExT Station; NExT Station Advanced2024-12-12
K240646 — DreamClear2024-09-04
K242305 — BE Plus PRO, Neurotravel LIGHT2024-09-04
K232210 — X-trodes System M2024-02-04

More clearances from Blackrock Microsystems

view all

K191346 — Blackrock NeuroCoG Subdural Cortical Electrodes (Strips and Grids)2020-02-14

Data sourced from openFDA. This site is unofficial and independent of the FDA.