Neurotronics, Inc.

Medical device manufacturer in Alachua, FL.

10510(k) clearances
0PMA approvals
0recalls

Device types

510(k) clearances

510(k)DeviceDecision
K251480PV01 PVDF Effort SensorSFK · Traditional 08/29/2025SE
K220631NomadAir PMU810GWL · Traditional 07/15/2022SE
K181709Serenity Piezo Sensor, Serenity Thermocouple SensorOLV · Traditional 11/16/2018SE
K173868Serenity Body Position Sensor, Serenity RIP SensorsOLV · Traditional 07/02/2018SE
K161650Polysmith Sleep System, Model NTI7593OLV · Traditional 01/19/2017SE
K142774Polysmith Sleep SystemOLV · Traditional 02/18/2015SE
K131415Live View Panel (LVP)OLV · Traditional 08/09/2013SE
K092699Nomad Sleep System Recorder, Model PMU800GWL · Traditional 03/18/2010SE
K062943Polysmith Sleep System, Model NTI5498OLZ · Traditional 05/09/2007SE
K971803Neurotronics Polysomnography System 101MNR · Traditional 11/12/1997SE