OLYMPIC BRAINZ MONITOR— 510(k) K123079

Substantially Equivalent

Excel-Tech Ltd. (Xltek)

FDA 510(k) clearance K123079 for OLYMPIC BRAINZ MONITOR, Substantially Equivalent on 2013-05-08. Applicant: Excel-Tech Ltd. (Xltek). Device class: 2.

Clearance details

Applicant: Excel-Tech Ltd. (Xltek)
Product code: Code OMA
Device class: Class 2
Regulation: 21 CFR 882.1400
Advisory panel: Neurology
Date received: 2012-10-01
Decision date: 2013-05-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Oakville, CA

Download summary PDF View on FDA.gov ↗

Recent devices under product code OMA

K192889 — Neo2020-01-30
K163644 — Nihon Kohden QP-160AK EEG Trend Program2017-05-19
K161027 — Cadwell AmpliScan2016-11-08
K152301 — Background Pattern Classification [BPc(TM)]2016-06-03
K130238 — NIHON KOHDEN AE-918P NEURO UNIT2015-03-04

More clearances from Excel-Tech Ltd. (Xltek)

K131266 — TREZ_HD2014-02-14
K120260 — ICTA2012-06-29
K090277 — NATUS SLEEPWORKS, MODEL 1040172011-04-19
K100126 — STELLATE GRIDVIEW2010-12-03
K081741 — NEUROLINK IP, MODEL PK11132008-10-31

Recalls naming K123079

K-number listed on FDA's recall record

Z-1925-2025 — Brand Name: OBM00002 OBM DAB (Digital Acquisition Box) Product Name: OBM00002 OBM DAB (Digital Acquisition Box) Model/Catalog Number: OBM00002 OBM DAB (Digital Acquisition Box) Software Version: N/A Product Description: OBM00002 OBM DAB (Digital Acquisition Box) Component: NoClass II·Ongoing·Natus Neurology DBA Excel Tech., Ltd. (XLTEK)·20250507
Z-1630-2020 — natus newborn care Olympic Brainz Monitor, REF OBM00002. electroencephalographClass II·Terminated·Natus Neurology DBA Excel Tech., Ltd. (XLTEK)·20200305

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K123079.

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