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510(k) K010965

A-LINE AEP MONITOR by Alaris Medical Systems, Inc. — Product Code OLW

K010965 is an FDA 510(k) premarket notification submitted by Alaris Medical Systems, Inc. for the device "A-LINE AEP MONITOR". The FDA issued a decision of Substantially Equivalent on Jun 27, 2001. The device falls under product code OLW (Index-Generating Electroencephalograph Software), a Class II device regulated under 21 CFR 882.1400. Alaris Medical Systems, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Jun 27, 2001
Date Received
Apr 2, 2001
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 Alaris Medical Systems, Inc.

  • K043299 — MEDLEY PCA MODULE, MODEL 8120 (Dec 10, 2004)
  • K041241 — MEDLEY SYSTEM WITH BAR CODE MODULE, MODEL 8600 (Jul 6, 2004)
  • K031741 — MEDLEY ETCO2 MODULE (INCLUDES ACCESSORIES), MODEL 8300 (Feb 9, 2004)
  • K032233 — MEDLEY PCA MODULE, MODEL 8120 (Sep 9, 2003)
  • K032147 — SIGNATURE EDITION INFUSION PUMP, SIGNATURE EDITION ADMINISTRATION SETS, MODELS 7 (Jul 25, 2003)
  • K030459 — MEDLEY SYSTEM WITH MEDICATION MANAGEMENT SYSTEM (MMS) (Apr 4, 2003)
  • K023264 — MEDLEY SYRINGE PUMP MODULE SYSTEM, MODEL 8110 (Dec 19, 2002)
  • K022677 — MEDLEY SPO2 MODULE, MODEL 8210 & SPO2 SENSORS & CABLE (Sep 11, 2002)
  • K022209 — ALARIS MEDICAL INFUSION SYSTEM ADMINISTRATION SETS (Aug 6, 2002)
  • K013087 — SINGLE DOSE DISPENSING PIN, MODEL 2201 (Nov 13, 2001)

Other clearances for product code OLW

  • K260907 — BIS™ Advance pEEG Module (Aug 13, 2026)
  • K260880 — SedLine Sedation Monitor (Jul 10, 2026)
  • K230693 — BIS™ Advance Monitoring System (Feb 26, 2024)
  • K213273 — Brain Anesthesia Response Monitor (Bar Monitor) (Sep 1, 2023)
  • K203113 — Masimo SedLine Sedation Monitor and Accessories (Feb 25, 2022)
  • K202621 — NeuroSENSE Monitoring System, Model NS-901 (Aug 5, 2021)
  • K172890 — SedLine Sedation Monitor (Jan 26, 2018)
  • K150298 — Entropy Module, E-ENTROPY-01 (Nov 12, 2015)
  • K083063 — BIS INTERFACE FOR VITALOGIK PATIENT MONITORS (Dec 16, 2008)
  • K061907 — MODIFICATION TO: DATEX-OHMEDA S/5 ENTROPY MODULE, E-ENTROPY AND ACCESSORIES (Mar 27, 2008)

FDA data resources