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510(k) K033999

SEDLINE WITH FRONTAL PSI by Physiometrix, Inc. — Product Code OLW

K033999 is an FDA 510(k) premarket notification submitted by Physiometrix, Inc. for the device "SEDLINE WITH FRONTAL PSI". The FDA issued a decision of Substantially Equivalent on February 6, 2004. The device falls under product code OLW (Index-Generating Electroencephalograph Software), a Class II device regulated under 21 CFR 882.1400. Physiometrix, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 6, 2004
Date Received
December 24, 2003
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Index-Generating Electroencephalograph Software
Device Class
Class II
Regulation Number
882.1400
Review Panel
NE
Submission Type

Analyze electrical activity of the brain by transformation of electroencephalograph signals into a dimensionless index number for use and interpretation by a qualified user.

Other clearances by Physiometrix, Inc.

  • K051874 — SEDLINE SEDATION MONITOR WITH FRONTAL PSI AND SEDTRACE EEG ELECTROSE SET (September 2, 2005)
  • K020670 — MODEL 4310 PSARRAY2 EEG ELECTRODE (October 8, 2002)
  • K020671 — PSA4000 EEG MONITOR WITH FRONTAL PSI (October 4, 2002)
  • K001069 — MODEL 4000 EEG MONITOR WITH PSI (PSA4000) (June 30, 2000)
  • K001055 — MODEL 4300 PSARRAY EEG ELECTRODE SET (May 11, 2000)
  • K970942 — MODEL 1320, NEUROLINK II NEUROMONITORING SYSTEM (June 2, 1997)
  • K970694 — MODEL 1700, HYDRO PREP (May 14, 1997)
  • K962447 — EQUINOX DIGITAL EEG SYSTEM (December 12, 1996)
  • K962157 — MODEL 1310 NEUROLINK NEUROMONITORING SYSTEM (November 25, 1996)
  • K961609 — MODEL 1220, OR E-NET (54-62 CM) (May 10, 1996)

Other clearances for product code OLW

  • K260880 — SedLine Sedation Monitor (July 10, 2026)
  • K230693 — BIS™ Advance Monitoring System (February 26, 2024)
  • K213273 — Brain Anesthesia Response Monitor (Bar Monitor) (September 1, 2023)
  • K203113 — Masimo SedLine Sedation Monitor and Accessories (February 25, 2022)
  • K202621 — NeuroSENSE Monitoring System, Model NS-901 (August 5, 2021)
  • K172890 — SedLine Sedation Monitor (January 26, 2018)
  • K150298 — Entropy Module, E-ENTROPY-01 (November 12, 2015)
  • K083063 — BIS INTERFACE FOR VITALOGIK PATIENT MONITORS (December 16, 2008)
  • K061907 — MODIFICATION TO: DATEX-OHMEDA S/5 ENTROPY MODULE, E-ENTROPY AND ACCESSORIES (March 27, 2008)
  • K072286 — BIS EEG VISTA MONITOR SYSTEM AND BISX (November 20, 2007)

FDA data resources