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510(k) K193159

NeuroAmp II, NeuroAmp II.5s by Corscience GmbH & Co. KG — Product Code GWQ

K193159 is an FDA 510(k) premarket notification submitted by Corscience GmbH & Co. KG for the device "NeuroAmp II, NeuroAmp II.5s". The FDA issued a decision of Substantially Equivalent on December 30, 2020. The device falls under product code GWQ (Full-Montage Standard Electroencephalograph), a Class II device regulated under 21 CFR 882.1400. Corscience GmbH & Co. KG has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 30, 2020
Date Received
November 15, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Full-Montage Standard Electroencephalograph
Device Class
Class II
Regulation Number
882.1400
Review Panel
NE
Submission Type

Acquire, display, store, and archive electroencephalographic signals from the brain using a full montage array (i.e., 16 or more electrodes) and user-specified locations

Other clearances by Corscience GmbH & Co. KG

  • K112077 — HBIDB - HUMAN BRIAN INDEX SOFTWARE (March 9, 2012)
  • K082077 — BT3/6, BT12 (September 2, 2008)
  • K073557 — EEG NEUROAMP, MODEL CS10137 (February 28, 2008)

Other clearances for product code GWQ

  • K261604 — Enobio Dx (Enobio Dx 8);Enobio Dx (Enobio Dx 20);Enobio Dx (Enobio Dx 32) (June 13, 2026)
  • K260455 — New Wave System (March 13, 2026)
  • K233403 — Flexset System (April 30, 2024)
  • K231366 — Neuronaute Plus (November 9, 2023)
  • K221959 — Q21 (August 31, 2023)
  • K231457 — SPARK Scan (August 18, 2023)
  • K221963 — Cumulus Functional Neurophysiology Platform (April 27, 2023)
  • K230073 — Okti (February 9, 2023)
  • K223644 — Neuronaute with IceCap 2 & IceCap 2 Small (January 12, 2023)
  • K220056 — iSyncWave (August 10, 2022)

FDA data resources