Home / 510(k) Clearances / K223676

510(k) K223676

SomniCheck by Brainmatterz, LLC — Product Code GWL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 1, 2023
Date Received
December 8, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Amplifier, Physiological Signal
Device Class
Class II
Regulation Number
882.1835
Review Panel
NE
Submission Type

Other clearances for product code GWL

  • K243746 — Delphi Amplifier (March 12, 2025)
  • K242832 — NExT Station; NExT Station Advanced (December 12, 2024)
  • K242305 — BE Plus PRO, Neurotravel LIGHT (September 4, 2024)
  • K240646 — DreamClear (September 4, 2024)
  • K232210 — X-trodes System M (February 4, 2024)
  • K230148 — Vlab (October 11, 2023)
  • K220631 — NomadAir PMU810 (July 15, 2022)
  • K203331 — Quick-20m (May 20, 2021)
  • K202174 — Digital NeuroPort Biopotential Signal Processing System (February 10, 2021)
  • K201747 — 8-CH Electroencephalography Amplifier (December 27, 2020)