Medical Device Manufacturer · US , Gainesville , FL

Neurotronics, Inc.

9 submissions · 9 cleared · Since 1997
9
Total
9
Cleared
0
Denied

Neurotronics, Inc. — FDA 510(k) Submissions

Neurotronics, Inc. has submitted 9 FDA 510(k) premarket notifications since 1997, of which 9 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Standard Polysomnograph With Electroencephalograph, Amplifier, Physiological Signal, Automatic Event Detection Software For Polysomnograph With Electroencephalograph, Ventilatory Effort Recorder . Use the specialty filter in the sidebar to narrow results.

9 devices
1–9 of 9
NomadAir PMU810
K220631 · GWL Amplifier, Physiological... · Neurology
Jul 2022 133d
Serenity Piezo Sensor, Serenity Thermocouple Sensor
K181709 · OLV Standard Polysomnograph... · Neurology
Nov 2018 141d
Serenity Body Position Sensor, Serenity RIP Sensors
K173868 · OLV Standard Polysomnograph... · Neurology
Jul 2018 194d
Polysmith Sleep System, Model NTI7593
K161650 · OLV Standard Polysomnograph... · Neurology
Jan 2017 218d
Polysmith Sleep System
K142774 · OLV Standard Polysomnograph... · Neurology
Feb 2015 145d
LIVE VIEW PANEL (LVP)
K131415 · OLV Standard Polysomnograph... · Neurology
Aug 2013 85d
NOMAD SLEEP SYSTEM RECORDER, MODEL PMU800
K092699 · GWL Amplifier, Physiological... · Neurology
Mar 2010 197d
POLYSMITH SLEEP SYSTEM, MODEL NTI5498
K062943 · OLZ Automatic Event Detection... · Neurology
May 2007 223d
NEUROTRONICS POLYSOMNOGRAPHY SYSTEM 101
K971803 · MNR Ventilatory Effort Recorder · Anesthesiology
Nov 1997 184d
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