Medical Device Manufacturer · US , Gainesville , FL

Neurotronics, Inc. - FDA 510(k) Cleared Devices

9 submissions · 9 cleared · Since 1997

Recent clearances: NomadAir PMU810, Serenity Piezo Sensor, Serenity Thermocouple Sensor, Serenity Body Position Sensor, Serenity RIP Sensors

9

Total

9

Cleared

0

Denied

FDA 510(k) Regulatory Record - Neurotronics, Inc. Neurology ✕

8 devices

1-8 of 8

Cleared Jul 15, 2022

NomadAir PMU810

Neurology · 133d

Cleared Nov 16, 2018

Serenity Piezo Sensor, Serenity Thermocouple Sensor

Neurology · 141d

Cleared Jul 02, 2018

Serenity Body Position Sensor, Serenity RIP Sensors

Neurology · 194d

Cleared Jan 19, 2017

Polysmith Sleep System, Model NTI7593

Neurology · 218d

Cleared Feb 18, 2015

Polysmith Sleep System

Neurology · 145d

Cleared Aug 09, 2013

LIVE VIEW PANEL (LVP)

Neurology · 85d

Cleared Mar 18, 2010

NOMAD SLEEP SYSTEM RECORDER, MODEL PMU800

Neurology · 197d

Cleared May 09, 2007

POLYSMITH SLEEP SYSTEM, MODEL NTI5498

Neurology · 223d