NEUROTRONICS, LLC

FDA Device Registration & Listing · Alachua, FL, US · Registration 1063925

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
1063925
FEI Number
3002459124
Entity Name
NEUROTRONICS, LLC
City/State/Country
Alachua, FL, US
Establishment Address
13800 Tech City Circle, Suite 400, Alachua, FL 32615, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
NEUROTRONICS, LLC (Owner Number: 9030449)
Owner / Operator Contact Address
13800 Tech City Circle, Suite 400, --, Alachua, FL 32615, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K251480
PMA Number
N/A

All Registered Proprietary Names

Serenity Piezo Sensor, Serenity Thermocouple Sensor Polysmith Sleep System Nomad Polysmith Sleep System, Model NTI7593 Polysmith Sleep System NTI6600 Serenity Body Position Sensor, Serenity RIP Sensors NomadAir NiteLynx PVDF Effort Sensor

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
OLV Standard Polysomnograph With Electroencephalograph Neurology Class 2 882.1400 2018-12-21
DQA Oximeter Cardiovascular Class 2 870.2700 2018-12-21
MNR Ventilatory Effort Recorder Anesthesiology Class 2 868.2375 2018-12-21
OLZ Automatic Event Detection Software For Polysomnograph With Electroencephalograph Neurology Class 2 882.1400 2018-12-21
GWL Amplifier, Physiological Signal Neurology Class 2 882.1835 2018-12-21
DQA Oximeter Cardiovascular Class 2 870.2700 2010-05-26
GWL Amplifier, Physiological Signal Neurology Class 2 882.1835 2010-05-26
MNR Ventilatory Effort Recorder Anesthesiology Class 2 868.2375 2010-05-26
OLZ Automatic Event Detection Software For Polysomnograph With Electroencephalograph Neurology Class 2 882.1400 2017-03-09
OLV Standard Polysomnograph With Electroencephalograph Neurology Class 2 882.1400 2017-03-09
DQA Oximeter Cardiovascular Class 2 870.2700 2017-03-09
MLO Electrocardiograph, Ambulatory, With Analysis Algorithm Cardiovascular Class 2 870.2800 2017-03-09
DQA Oximeter Cardiovascular Class 2 870.2700 2015-06-08
OLV Standard Polysomnograph With Electroencephalograph Neurology Class 2 882.1400 2015-06-08
OLZ Automatic Event Detection Software For Polysomnograph With Electroencephalograph Neurology Class 2 882.1400 2015-06-08
OLV Standard Polysomnograph With Electroencephalograph Neurology Class 2 882.1400 2018-10-30
MNR Ventilatory Effort Recorder Anesthesiology Class 2 868.2375 2022-12-19
GWL Amplifier, Physiological Signal Neurology Class 2 882.1835 2022-12-19
SFK Respiratory Effort Belt For Polysomnography Neurology Class 2 882.1400 2025-09-23

Official Correspondent

James Smith

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

NEUROTRONICS, LLC
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
K161650 Neurotronics, Inc. Polysmith Sleep System, Model NTI7593 2017-01-19
K903523 Hewlett-Packard Co. HP MODEL M1020A, ARTERIAL OXYGEN SAT/PLETH MODULE 1990-10-23
K973147 Nellcor Puritan Bennett, Inc. NPB-295 PULSE OXIMETER 1997-11-14
K231243 Guangdong Genial Technology Co., Ltd. Finger Clip Pulse Oximeter 2023-10-31
K971628 Somanetics Corp. SOMANETICS INVOS 3100A CEREBRAL OXIMETER (INVOS) 1997-10-10

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0020-2019 Oridion Medical 1987 Ltd. Har Hotzvim Industrial 2
CAPNOSTREAM 20 (US) N, Part Number CS08651
Z-0022-2019 Oridion Medical 1987 Ltd. Har Hotzvim Industrial 2
CAPNOSTREAM 20P (US) N - ROHS, Part Number CS08651-02
Z-0023-2019 Oridion Medical 1987 Ltd. Har Hotzvim Industrial 2
CAPNOSTREAM 20P (US) N - ROHS, Part Number CS08651-03
Z-0028-2019 Oridion Medical 1987 Ltd. Har Hotzvim Industrial 2
Capnostream20 (US) M, Part Number CS08653
Z-0029-2019 Oridion Medical 1987 Ltd. Har Hotzvim Industrial 2
Capnostream20 (US) M W/PRINTER, Part Number CS08659

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1063925. Last updated year: 2026. Please use registration number 1063925 when referencing this establishment in official correspondence.
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