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510(k) K212325

EEG-acp by Somnomedics GmbH — Product Code GYB

K212325 is an FDA 510(k) premarket notification submitted by Somnomedics GmbH for the device "EEG-acp". The FDA issued a decision of Substantially Equivalent on June 15, 2022. The device falls under product code GYB (Media, Electroconductive), a Class II device regulated under 21 CFR 882.1275. Somnomedics GmbH has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 15, 2022
Date Received
July 26, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Media, Electroconductive
Device Class
Class II
Regulation Number
882.1275
Review Panel
NE
Submission Type

Other clearances by Somnomedics GmbH

  • K240700 — HomeSleepTest (HST, HST REM+) (December 8, 2024)
  • K231104 — ABPMpro (November 27, 2023)
  • K201054 — SOMNOscreen plus (August 12, 2020)
  • K140861 — SOMNOTOUCH RESP (January 30, 2015)
  • K081485 — SOMNOWATCH (September 18, 2008)
  • K071556 — SOMNOSCREEN EEG10-20 (July 18, 2007)

Other clearances for product code GYB

  • K243749 — Jmoon Conductive Gel (April 8, 2025)
  • K220735 — Avologi Gel Primer (Model: Av25) (September 15, 2023)
  • K222770 — Conductive Gel (December 13, 2022)
  • K221724 — Conductive Gel (September 23, 2022)
  • K212326 — AC Cream - Conductive paste (December 1, 2021)
  • K212787 — GT5 conductive & abrasive gel (November 8, 2021)
  • K200402 — DR-HO'S Electro Therapy Conductive Gel (November 25, 2020)
  • K191975 — Elefix V Paste for EEG & EMG (February 7, 2020)
  • K192606 — SAC2 - Electrode Cream (January 17, 2020)
  • K190050 — Tech Dots - Adhesive and conductive gel (July 19, 2019)

FDA data resources