BIS EEG VISTA MONITOR SYSTEM AND BISX— 510(k) K072286

Name: FDA 510(k) clearance K072286
Creator: U.S. Food and Drug Administration
Published: 2007-11-20

Substantially Equivalent

Aspect Medical Systems, Inc.

FDA 510(k) clearance K072286 for BIS EEG VISTA MONITOR SYSTEM AND BISX, Substantially Equivalent on 2007-11-20. Applicant: Aspect Medical Systems, Inc.. Device class: 2.

Clearance details

Applicant: Aspect Medical Systems, Inc.
Product code: Code OLW
Device class: Class 2
Regulation: 21 CFR 882.1400
Advisory panel: Neurology
Date received: 2007-08-16
Decision date: 2007-11-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Norwood, 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 Aspect Medical Systems, Inc.

view all

K093183 — BIS QUATRO SENSOR2009-10-23
K091854 — BIS CLICK SENSOR/CABLE2009-07-02
K062613 — BIS EEG MONITOR VIEW2007-06-18
K070069 — ZIPPREP ELECTRODE2007-02-05
K062692 — BIS BILATERAL SENSOR2006-12-13

Recalls naming K072286

K-number listed on FDA's recall record

Z-2958-2018 — Li-ion battery packs used in BIS Vista and BIS View Monitoring Systems. Product Number/CFN: 186-0208 UDI-Device Identifier (GTIN/UPN): 10884521130319Class II·Ongoing·Covidien LLC·20180726

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K072286.

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