Neurotronics, LLC
Alachua, FL, US
NEUROTRONICS, LLC appears in FDA device records in Alachua, FL. FDA records list 10 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 10 510(k) clearances for Neurotronics, LLC between 1997 and 2025. The busiest year on record is 2018, with 2. The most recent is 2025, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1997 | 1 |
| 2007 | 1 |
| 2010 | 1 |
| 2013 | 1 |
| 2015 | 1 |
| 2017 | 1 |
| 2018 | 2 |
| 2022 | 1 |
| 2025 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K251480 | PV01 PVDF Effort Sensor | SFK | Substantially Equivalent | |
| K220631 | NomadAir PMU810 | GWL | Substantially Equivalent | |
| K181709 | Serenity Piezo Sensor, Serenity Thermocouple Sensor | OLV | Substantially Equivalent | |
| K173868 | Serenity Body Position Sensor, Serenity RIP Sensors | OLV | Substantially Equivalent | |
| K161650 | Polysmith Sleep System, Model NTI7593 | OLV | Substantially Equivalent | |
| K142774 | Polysmith Sleep System | OLV | Substantially Equivalent | |
| K131415 | LIVE VIEW PANEL (LVP) | OLV | Substantially Equivalent | |
| K092699 | NOMAD SLEEP SYSTEM RECORDER, MODEL PMU800 | GWL | Substantially Equivalent | |
| K062943 | POLYSMITH SLEEP SYSTEM, MODEL NTI5498 | OLZ | Substantially Equivalent | |
| K971803 | NEUROTRONICS POLYSOMNOGRAPHY SYSTEM 101 | MNR | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1063925 | 3002459124 | NEUROTRONICS, LLC | 13800 Tech City Circle, Suite 400, Alachua, FL 32615 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- GWLAmplifier, Physiological Signal
- OLZAutomatic Event Detection Software For Polysomnograph With Electroencephalograph
- MLOElectrocardiograph, Ambulatory, With Analysis Algorithm
- GWQFull-Montage Standard Electroencephalograph
- OLTNon-Normalizing Quantitative Electroencephalograph Software
- DQAOximeter
- SFKRespiratory Effort Belt For Polysomnography
- OLVStandard Polysomnograph With Electroencephalograph
- MNRVentilatory Effort Recorder
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain