NICOLET WIRELESS EEG— 510(k) K103140

Substantially Equivalent

Carefusion 209, Inc.

FDA 510(k) clearance K103140 for NICOLET WIRELESS EEG, Substantially Equivalent on 2011-04-08. Applicant: Carefusion 209, Inc.. Device class: 2.

Clearance details

Applicant: Carefusion 209, Inc.
Product code: Code GWL
Device class: Class 2
Regulation: 21 CFR 882.1835
Advisory panel: Neurology
Date received: 2010-10-25
Decision date: 2011-04-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Middleton, WI, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code GWL

K243746 — Delphi Amplifier2025-03-12
K242832 — NExT Station; NExT Station Advanced2024-12-12
K240646 — DreamClear2024-09-04
K242305 — BE Plus PRO, Neurotravel LIGHT2024-09-04
K232210 — X-trodes System M2024-02-04

More clearances from Carefusion 209, Inc.

K120979 — CAREFUSION NICOLET EDX2012-04-25
K112052 — CAREFUSION NICOLET EDX2012-03-15
K112034 — TECA ELITE DISPOSABLE CONCENTRIC NEEDLES2011-08-12
K111131 — TECA (TM) ELITE DISPOSABLE MONOPOLAR NEEDLES2011-06-17

Recalls naming K103140

K-number listed on FDA's recall record

Z-0946-2013 — Nicolet EEG Wireless Amplifier 32/64 Channel. Catalog/Part Numbers : 515-015400 for the 32 channel amplifier and 515-015500 for the 64 channel amplifier. Product Usage: The Nicolet Wireless EEG Amplifier is intended to be used as a front end amplifier to acquire, store, and transmit electrophysiological signals in a wired or wireless mode for the Nicolet Neurodiagnostic system.Class II·Terminated·Natus Neurology Incorporated·20130227

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K103140.

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