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510(k) K060900

SPACELABS MEDICAL BISPECTRAL INDEX (BISX) ANALYSIS MODULE 91482 AND ACCESSORIES MODEL-91842 by Spacelabs Medical, Inc. — Product Code OLW

K060900 is an FDA 510(k) premarket notification submitted by Spacelabs Medical, Inc. for the device "SPACELABS MEDICAL BISPECTRAL INDEX (BISX) ANALYSIS MODULE 91482 AND ACCESSORIES MODEL-91842". The FDA issued a decision of Substantially Equivalent on June 23, 2006. The device falls under product code OLW (Index-Generating Electroencephalograph Software), a Class II device regulated under 21 CFR 882.1400. Spacelabs Medical, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 23, 2006
Date Received
April 3, 2006
Clearance Type
Traditional
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 Spacelabs Medical, Inc.

  • K120616 — SPACELABS HEALTHCARE QUBE COMPACT MONITOR (91390 (March 29, 2012)
  • K112962 — SPACELABS HEALTHCARE XPREZZON BESIDE MONITOR(9913930) (November 2, 2011)
  • K102422 — SPACELABS MEDICAL PATIENT MONITORS (December 7, 2010)
  • K093501 — ELANCE VITAL SIGNS MONITOR AND ELANCE CENTRAL STATION (November 24, 2009)
  • K082045 — MODIFICATION TO MCARE 300 VITAL SIGNS MONITOR, MODEL 91220 (August 1, 2008)
  • K063490 — SPACELABS MEDICAL FULL DISCLOSURE SYSTEM, MODEL 91810 (March 15, 2007)
  • K062095 — MCARE 300 VITAL SIGNS MONITOR, MODEL 91220 (September 29, 2006)
  • K062278 — SPACELABS MEDICAL CLINICAL EVENT INTERFACE, MODEL 91847 (September 19, 2006)
  • K053599 — SPACELABS MEDICAL MULTIGAS ANALYZER MODULE 91518 AND ACCESSORIES (April 19, 2006)
  • K050605 — SPACELABS MEDICAL MULTIPARAMETER MODULE 91496 (May 3, 2005)

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