Data / Medical devices / United States / Neurowave Systems Inc.

Neurowave Systems Inc.: FDA-registered device maker in Beachwood, OH, United States, 1 510(k) clearance

Name: Neurowave Systems Inc. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Neurowave Systems Inc. is registered with the FDA (registration 3008657519) in Beachwood, OH, United States. It lists 5 device types. The FDA files 1 510(k) clearance under its listings, the newest dated August 5, 2021. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3008657519
Address: 25825 Science Park Dr, STE 250, Beachwood, OH, United States, 44122
Owner or operator: NeuroWave Systems Inc. (10033810)
Roles: Manufacturer
First device listed: November 21, 2022
Registered through: 2026
Brand names listed: NeuroSENSE Monitoring System, Model NS-901, with EasyPrep Electrodes EK-901

Devices it lists

Device	Product code	Class	Role	Source
Burst Suppression Detection Software For Electroencephalograph	ORT	2	Manufacturer	accessdata.fda.gov
Electrode, Cutaneous	GXY	2	Manufacturer	accessdata.fda.gov
Index-Generating Electroencephalograph Software	OLW	2	Manufacturer	accessdata.fda.gov
Non-Normalizing Quantitative Electroencephalograph Software	OLT	2	Manufacturer	accessdata.fda.gov
Reduced- Montage Standard Electroencephalograph	OMC	2	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
August 5, 2021	K202621	NeuroSENSE Monitoring System, Model NS-901	OLW	Substantially Equivalent	Neurowave Systems, Inc.	accessdata.fda.gov

Compare with other makers

Updated August 5, 2021. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.