Data / Medical devices / United States / Neurotronics, LLC

Neurotronics, LLC: FDA-registered device maker in Alachua, FL, United States, 8 510(k) clearances

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

Neurotronics, LLC is registered with the FDA (registration 1063925) in Alachua, FL, United States. It lists 9 device types. The FDA files 8 510(k) clearances under its listings, the newest dated August 29, 2025. Registered through 2026. FDA data exported November 2, 2026.

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Get makers like this one Watch Neurotronics, LLC

FDA registration number: 1063925
FEI number: 3002459124
Address: 13800 Tech City Circle, Suite 400, Alachua, FL, United States, 32615
Owner or operator: NEUROTRONICS, LLC (9030449)
Roles: Manufacturer
First device listed: May 26, 2010
Registered through: 2026
Brand names listed: Live View Panel (LVP), Live View Panel (LVP) Pro, NiteLynx PVDF Effort Sensor, Nomad, NomadAir, Polysmith Sleep System, Polysmith Sleep System NTI6600, Polysmith Sleep System, Model NTI7593 and more

Devices it lists

Device	Product code	Class	Role	Source
Amplifier, Physiological Signal	GWL	2	Manufacturer	accessdata.fda.gov
Automatic Event Detection Software For Polysomnograph With Electroencephalograph	OLZ	2	Manufacturer	accessdata.fda.gov
Electrocardiograph, Ambulatory, With Analysis Algorithm	MLO	2	Manufacturer	accessdata.fda.gov
Full-Montage Standard Electroencephalograph	GWQ	2	Manufacturer	accessdata.fda.gov
Non-Normalizing Quantitative Electroencephalograph Software	OLT	2	Manufacturer	accessdata.fda.gov
Oximeter	DQA	2	Manufacturer	accessdata.fda.gov
Respiratory Effort Belt For Polysomnography	SFK	2	Manufacturer	accessdata.fda.gov
Standard Polysomnograph With Electroencephalograph	OLV	2	Manufacturer	accessdata.fda.gov
Ventilatory Effort Recorder	MNR	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 29, 2025	K251480	PV01 PVDF Effort Sensor	SFK	Substantially Equivalent	Neurotronics, LLC	accessdata.fda.gov
July 15, 2022	K220631	NomadAir PMU810	GWL	Substantially Equivalent	Neurotronics, Inc.	accessdata.fda.gov
November 16, 2018	K181709	Serenity Piezo Sensor, Serenity Thermocouple Sensor	OLV	Substantially Equivalent	Neurotronics, Inc.	accessdata.fda.gov
July 2, 2018	K173868	Serenity Body Position Sensor, Serenity RIP Sensors	OLV	Substantially Equivalent	Neurotronics, Inc.	accessdata.fda.gov
January 19, 2017	K161650	Polysmith Sleep System, Model NTI7593	OLV	Substantially Equivalent	Neurotronics, Inc.	accessdata.fda.gov
February 18, 2015	K142774	Polysmith Sleep System	OLV	Substantially Equivalent	Neurotronics, Inc.	accessdata.fda.gov
August 9, 2013	K131415	LIVE VIEW PANEL (LVP)	OLV	Substantially Equivalent	Neurotronics, Inc.	accessdata.fda.gov
March 18, 2010	K092699	NOMAD SLEEP SYSTEM RECORDER, MODEL PMU800	GWL	Substantially Equivalent	Neurotronics, Inc.	accessdata.fda.gov

Compare with other makers

Updated August 29, 2025. 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.