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510(k) K843598

BRAIN FUNCTION MAPPING OPTION FOR PATHF by Nicolet Biomedical Instruments — Product Code GWK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 11, 1985
Date Received
September 12, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Conditioner, Signal, Physiological
Device Class
Class II
Regulation Number
882.1845
Review Panel
NE
Submission Type

Other clearances by Nicolet Biomedical Instruments

  • K880573 — MODIFIED NICOLET VIKING SYSTEM (March 22, 1988)
  • K873736 — NICOLET DIGITAL TWO PIECE HEARING AID (December 8, 1987)
  • K873964 — NICOLET DISPOSABLE PRASS PROBE (November 20, 1987)
  • K873535 — NICOLET EXPERT SLEEP/WAKE ANALYSIS SYSTEM (October 26, 1987)
  • K871678 — NICOLET AMP 6R11 SYSTEM (July 16, 1987)
  • K862592 — PHOENIX SYSTEM SEVEN. (September 16, 1986)
  • K851190 — NYSTAGMOGRAPH EOG/ENG ANALYSES (November 27, 1985)
  • K850259 — ELECTROENCEPHALOGRAPH EEG (April 11, 1985)
  • K850108 — EMG SURFACE, DIGITAL RING, BAR, GROUNDING, EEG (April 11, 1985)
  • K850107 — CONCENTRIC NEEDLE ELECTRODES-VARIOUS SIZES W/CONNE (April 11, 1985)

Other clearances for product code GWK

  • K060919 — ACTICAL (September 22, 2006)
  • K061870 — VITALSENSE XHR (August 31, 2006)
  • K052489 — ACTIHEART (September 27, 2005)
  • K991045 — MINI-LOGGER SERIES 2000 (September 21, 1999)
  • K905594 — NEUROFILE DATA STORAGE/ACCESORIES TO THE EEG-4300 (June 28, 1991)
  • K904328 — VISTA POLYSOMNOGRAPHY COMPUTER SYSTEM (June 18, 1991)
  • K896164 — ASC-954 INTEGRATOR AMPLIFIER (January 22, 1990)
  • K882599 — NICOLET BRAINLAB SYSTEM (October 19, 1988)
  • K872290 — BIO-LOGIC BANKER (October 6, 1987)
  • K870381 — DD-VCR-64 (March 25, 1987)