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Neurotronics, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
10
Inspections
5
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K251480PV01 PVDF Effort SensorAugust 29, 2025
K220631NomadAir PMU810July 15, 2022
K181709Serenity Piezo Sensor, Serenity Thermocouple SensorNovember 16, 2018
K173868Serenity Body Position Sensor, Serenity RIP SensorsJuly 2, 2018
K161650Polysmith Sleep System, Model NTI7593January 19, 2017
K142774Polysmith Sleep SystemFebruary 18, 2015
K131415LIVE VIEW PANEL (LVP)August 9, 2013
K092699NOMAD SLEEP SYSTEM RECORDER, MODEL PMU800March 18, 2010
K062943POLYSMITH SLEEP SYSTEM, MODEL NTI5498May 9, 2007
K971803NEUROTRONICS POLYSOMNOGRAPHY SYSTEM 101November 12, 1997