Natus Brain Monitor Amplifier— 510(k) K180290

Name: FDA 510(k) clearance K180290
Creator: U.S. Food and Drug Administration
Published: 2018-06-14

Substantially Equivalent

Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)

FDA 510(k) clearance K180290 for Natus Brain Monitor Amplifier, Substantially Equivalent on 2018-06-14. Applicant: Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek). Device class: 2.

Clearance details

Applicant: Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)
Product code: Code GWQ
Device class: Class 2
Regulation: 21 CFR 882.1400
Advisory panel: Neurology
Date received: 2018-02-01
Decision date: 2018-06-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Oakville, CA

Download summary PDF View on FDA.gov ↗

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Recalls naming K180290

K-number listed on FDA's recall record

Z-2138-2025 — Natus Brain Monitor Breakout Box, Part Number 021911; full-montage standard electroencephalographClass II·Ongoing·Natus Neurology DBA Excel Tech., Ltd. (XLTEK)·20250618

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K180290.

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