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510(k) K800452

NEUROMETRICS MONITOR by Neurometrics — Product Code GWS

K800452 is an FDA 510(k) premarket notification submitted by Neurometrics for the device "NEUROMETRICS MONITOR". The FDA issued a decision of Substantially Equivalent on April 2, 1980. The device falls under product code GWS (Analyzer, Spectrum, Electroencephalogram Signal), a Class I device regulated under 21 CFR 882.1420. Neurometrics has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 2, 1980
Date Received
February 28, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Analyzer, Spectrum, Electroencephalogram Signal
Device Class
Class I
Regulation Number
882.1420
Review Panel
NE
Submission Type

Other clearances by Neurometrics

  • K861900 — LIFESCAN EVOKED POTENTIAL SYSTEM (August 25, 1986)
  • K841790 — LIFESCAN EEG MONITOR (July 12, 1984)

Other clearances for product code GWS

  • K974718 — PERSYST PRISM (March 9, 1998)
  • K925735 — EEG ANALYZER (December 3, 1993)
  • K912938 — RHYTHM (July 30, 1991)
  • K894629 — NICOLET BEAM II SYSTEM (March 9, 1990)
  • K871931 — ISTAT SOFTWARE (October 13, 1987)
  • K871480 — STD-228 SPECTRAL TREND DISPLAY (May 1, 1987)
  • K854662 — OEE_7102 EEG/TREND MONITOR (August 20, 1986)
  • K860829 — CNS 4/8 AND CT 48.1 SOFTWARE (May 29, 1986)
  • K854160 — CNS-16 & LTM 1.0 SOFTWARE (January 10, 1986)
  • K850430 — NEUROSCIENCE MAP-10 EEG (July 17, 1985)

FDA data resources