NEUROWAVE SYSTEMS INC.

FDA Device Registration & Listing · Beachwood, OH, US · Registration 3008657519

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3008657519
FEI Number
3008657519
Entity Name
NEUROWAVE SYSTEMS INC.
City/State/Country
Beachwood, OH, US
Establishment Address
25825 Science Park Dr, STE 250, Beachwood, OH 44122, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
NeuroWave Systems Inc. (Owner Number: 10033810)
Owner / Operator Contact Address
25825 Science Park, STE 250, Beachwood, OH 44122, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K202621
PMA Number
N/A

All Registered Proprietary Names

NeuroSENSE Monitoring System, Model NS-901, with EasyPrep Electrodes EK-901

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
ORT Burst Suppression Detection Software For Electroencephalograph Neurology Class 2 882.1400 2022-11-21
GXY Electrode, Cutaneous Neurology Class 2 882.1320 2022-11-21
OMC Reduced- Montage Standard Electroencephalograph Neurology Class 2 882.1400 2022-11-21
OLT Non-Normalizing Quantitative Electroencephalograph Software Neurology Class 2 882.1400 2022-11-21
OLW Index-Generating Electroencephalograph Software Neurology Class 2 882.1400 2022-11-21

Official Correspondent

Tatjana Zikov

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

NeuroWave Systems Inc.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K070612 Top-Rank Health Care Equipment Co., Ltd. TOP-RANK ADHESIVE ELECTRODE 2007-05-07
K123915 Grass Technologies, an Astro-Med, Inc. Product Gro DE48-PLUS 2013-04-24
K073532 Technomed Europe DISPOSABLE ADHESIVE SURFACE ELECTRODES, DISC ELECTRODES 2008-05-01
K260363 Ceribell, Inc. Ceribell Brain Monitor Headband 2026-04-03
K091762 Covidien DURA-STICK SELF-ADHESIVE ELECTRODES WITH ALOE 2009-12-22

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008657519. Last updated year: 2026. Please use registration number 3008657519 when referencing this establishment in official correspondence.
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