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510(k) K921927

NICOLET VOYAGEUR by Nicolet Instrument Corp. — Product Code GWQ

K921927 is an FDA 510(k) premarket notification submitted by Nicolet Instrument Corp. for the device "NICOLET VOYAGEUR". The FDA issued a decision of Substantially Equivalent on November 5, 1992. The device falls under product code GWQ (Full-Montage Standard Electroencephalograph), a Class II device regulated under 21 CFR 882.1400. Nicolet Instrument Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 5, 1992
Date Received
April 24, 1992
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 Nicolet Instrument Corp.

  • K921138 — NICOLET ULTRASOM ACQUISITION STATION (May 14, 1993)
  • K923315 — NICOLET ARK SYSTEM (November 23, 1992)
  • K915652 — NICOLET PORATBLE SPIRIT SYSTEM (February 7, 1992)
  • K905632 — NICOLET MAPLELEAF SYSTEM (June 7, 1991)
  • K897154 — NICOLET DBTE HEARING AID: DIGITAL & PROGRAMMABLE (April 30, 1990)
  • K894629 — NICOLET BEAM II SYSTEM (March 9, 1990)
  • K896477 — NICOLET REAL EAR ANALYZER (February 8, 1990)
  • K883781 — NICOLET NEUROPORT/ACE SYSTEM (June 5, 1989)
  • K890495 — NICOLET VIKING II SYSTEM (March 16, 1989)
  • K884294 — NICOLET NYSTAR PLUS SYSTEM (November 23, 1988)

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