FDA 510(k) Applications Submitted by NEUROTRONICS, INC.

FDA 510(k) Number Submission Date Device Name Applicant
K131415 05/16/2013 LIVE VIEW PANEL (LVP) NEUROTRONICS, INC.
K161650 06/15/2016 Polysmith Sleep System, Model NTI7593 Neurotronics, Inc.
K181709 06/28/2018 Serenity Piezo Sensor, Serenity Thermocouple Sensor Neurotronics, Inc.
K142774 09/26/2014 Polysmith Sleep System Neurotronics, Inc.
K173868 12/20/2017 Serenity Body Position Sensor, Serenity RIP Sensors Neurotronics, Inc.
K971803 05/12/1997 NEUROTRONICS POLYSOMNOGRAPHY SYSTEM 101 NEUROTRONICS, INC.
K092699 09/02/2009 NOMAD SLEEP SYSTEM RECORDER, MODEL PMU800 NEUROTRONICS, INC.
K220631 03/04/2022 NomadAir PMU810 Neurotronics, Inc.
K062943 09/28/2006 POLYSMITH SLEEP SYSTEM, MODEL NTI5498 NEUROTRONICS, INC.


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