Home / 510(k) Clearances / K904269

510(k) K904269

NEUROSEARCH-24 OR NRS-24 by Lexicor Medical Technology, Inc. — Product Code GWQ

K904269 is an FDA 510(k) premarket notification submitted by Lexicor Medical Technology, Inc. for the device "NEUROSEARCH-24 OR NRS-24". The FDA issued a decision of Substantially Equivalent on June 4, 1991. The device falls under product code GWQ (Full-Montage Standard Electroencephalograph), a Class II device regulated under 21 CFR 882.1400. Lexicor Medical Technology, Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 4, 1991
Date Received
September 18, 1990
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 Lexicor Medical Technology, Inc.

  • DEN110019 — NEBA SYSTEM (July 15, 2013)
  • K961645 — MRS-2D (October 31, 1996)
  • K915820 — NEUROSEARCH-24 OR NRS-24 (February 8, 1995)

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