Nicolet Amp 6R11 System

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K871678 ↗

FDA Product Code

GWL

Device Class

Class II

Regulation

21 CFR Part 882.1835

Advisory Committee

Neurology

FDA Decision

SESE Substantially Equivalent

• EMG Surface, Digital Ring, Bar, Grounding, EEG

  Class II

  FDA 510(k) K850108 Active Cleared 11 Apr 1985

• Nicolet Viking

  Class II

  FDA 510(k) K842956 Active Cleared 3 Aug 1984

• Nic-200 Ventricular Function Analyzer

  Class I

  FDA 510(k) K792466 Active Cleared 24 Jan 1980

• Arteoial Tonometer Ml-105

  Class II

  FDA 510(k) K771449 Active Cleared 6 Sep 1977

• Compact Visual

  Class II

  FDA 510(k) K842613 Active Cleared 20 Jul 1984

• Brain Function Mapping Option for Pathf

  Class II

  FDA 510(k) K843598 Active Cleared 11 Apr 1985

See all devices from Nicolet Biomedical Instruments →

• What is the Nicolet Amp 6r11 System used for?

  The Nicolet Amp 6r11 System is intended for use in neurology applications as indicated by its advisory committee classification under product code GWL and regulation number 882.1835 for amplifying physiological signals.

• How was the Nicolet Amp 6r11 System cleared for market?

  The Nicolet Amp 6r11 System was cleared via the traditional 510(k) pathway as a substantially equivalent device under K871678, based on its classification under product code GWL and regulation number 882.1835.

• Who manufactures the Nicolet Amp 6r11 System and where is it located?

  The Nicolet Amp 6r11 System is manufactured by Nicolet Biomedical Instruments, located at 5225-4 Verona Rd., P.O. Box 4287, Madison, WI 53711, United States.