MODEL 4000 EEG MONITOR WITH PSI (PSA4000)— 510(k) K001069

Name: FDA 510(k) clearance K001069
Creator: U.S. Food and Drug Administration
Published: 2000-06-30

Substantially Equivalent

Physiometrix, Inc.

FDA 510(k) clearance K001069 for MODEL 4000 EEG MONITOR WITH PSI (PSA4000), Substantially Equivalent on 2000-06-30. Applicant: Physiometrix, Inc.. Device class: 2.

Clearance details

Applicant: Physiometrix, Inc.
Product code: Code OLW
Device class: Class 2
Regulation: 21 CFR 882.1400
Advisory panel: Neurology
Date received: 2000-04-03
Decision date: 2000-06-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: North Billerica, MA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code OLW

view all

K260907 — BIS Advance pEEG Module2026-08-13
K260880 — SedLine Sedation Monitor2026-07-10
K230693 — BIS Advance Monitoring System2024-02-26
K213273 — Brain Anesthesia Response Monitor (Bar Monitor)2023-09-01
K203113 — Masimo SedLine Sedation Monitor and Accessories2022-02-25

More clearances from Physiometrix, Inc.

view all

K051874 — SEDLINE SEDATION MONITOR WITH FRONTAL PSI AND SEDTRACE EEG ELECTROSE SET2005-09-02
K033999 — SEDLINE WITH FRONTAL PSI2004-02-06
K020670 — MODEL 4310 PSARRAY2 EEG ELECTRODE2002-10-08
K020671 — PSA4000 EEG MONITOR WITH FRONTAL PSI2002-10-04
K001055 — MODEL 4300 PSARRAY EEG ELECTRODE SET2000-05-11

Data sourced from openFDA. This site is unofficial and independent of the FDA.