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510(k) K912938

RHYTHM by Stellate Systems — Product Code GWS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 30, 1991
Date Received
July 5, 1991
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 Stellate Systems

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  • K982351 — LUNA (July 29, 1998)
  • K955577 — ECLIPSE VERSION 3.0 (September 20, 1996)
  • K960273 — HARMONIE SENSA (April 4, 1996)

Other clearances for product code GWS

  • K974718 — PERSYST PRISM (March 9, 1998)
  • K925735 — EEG ANALYZER (December 3, 1993)
  • 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)
  • K844481 — NEUROLAB II (May 20, 1985)