Neurotronics Inc

FDA Filings

This page includes the latest FDA filings for Neurotronics Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
Registration Number1063925
FEI Number3002459124
NameNEUROTRONICS, INC.
Owner & OperatorNEUROTRONICS, INC.
Contact Address4500 NW 27th AVE STE C2 --
Gainesville FL 32606 US
Official Correspondent
  • DAVID PEZET
  • x-352-3729955-512
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address4500 NW 27th AVE STE C2
Gainesville, FL 32606 US
Establishment TypeManufacture Medical Device



FDA Filings

Device
Company
DeviceDate
Neurotronics, Inc.
NomadAir PMU8102022-07-15
NEUROTRONICS, INC.
Polysmith Version 12.0 2020-04-09
NEUROTRONICS, INC.
Live View Panel Version 1.4 2019-12-11
NEUROTRONICS, INC.
Live View Panel Version 1.3 2019-12-11
NEUROTRONICS, INC.
Polysmith Version 11.0 2019-12-11
NEUROTRONICS, INC.
Polysmith Version 9.0 2019-12-11
NEUROTRONICS, INC.
Polysmith Version 10.0 2019-12-11
NEUROTRONICS, INC.
Serenity PZ01 Piezo Sensor, 249 Keyhole, 3.0m S831112019-05-09
NEUROTRONICS, INC.
Serenity PZ01 Piezo Sensor, 1.5mm DIN, 3.0m S528972019-05-09
NEUROTRONICS, INC.
Nomad PMU800 Portable Recorder (USB) N111332019-05-09
NEUROTRONICS, INC.
Nomad PMU800 Portable Recorder N682722019-02-13
NEUROTRONICS, INC.
Serenity TH01 Thermocouple Sensor w/ Hanger, 249 Keyhole, 2.0m S475812019-01-28
NEUROTRONICS, INC.
Serenity TH01 Thermocouple Sensor w/ Hanger, 249 Keyhole, 0.6m S211092019-01-28
NEUROTRONICS, INC.
Serenity TH01 Thermocouple Sensor w/ Hanger, 1.5mm DIN, 2.0m S583172019-01-28
NEUROTRONICS, INC.
Serenity TH01 Thermocouple Sensor w/ Hanger, 1.5mm DIN, 1.2m S532602019-01-28
NEUROTRONICS, INC.
Serenity TH01 Thermocouple Sensor w/ Hanger, 1.5mm DIN, 0.6m S600122019-01-28
NEUROTRONICS, INC.
Serenity TH01 Thermocouple Sensor, 249 Keyhole, 2.0m S406612019-01-28
NEUROTRONICS, INC.
Serenity TH01 Thermocouple Sensor, 249 Keyhole, 0.6m S400502019-01-28
NEUROTRONICS, INC.
Serenity TH01 Thermocouple Sensor, 1.5mm DIN, 2.0m S280852019-01-28
NEUROTRONICS, INC.
Serenity TH01 Thermocouple Sensor, 1.5mm DIN, 1.2m S153022019-01-28
NEUROTRONICS, INC.
Serenity TH01 Thermocouple Sensor, 1.5mm DIN, 0.6m S296042019-01-28
NEUROTRONICS, INC.
Serenity PZ01 Piezo Sensor, 249 Keyhole, 0.6m S773502019-01-28
NEUROTRONICS, INC.
Serenity PZ01 Piezo Sensor, 249 Keyhole, 2.0m S610602019-01-28
NEUROTRONICS, INC.
Serenity PZ01 Piezo Sensor, 1.5mm DIN, 0.6m S944162019-01-28
NEUROTRONICS, INC.
Serenity PZ01 Piezo Sensor, 1.5mm DIN, 2.0m S607802019-01-28
NEUROTRONICS, INC.
Serenity Piezo Sensor, Serenity Thermocouple Sensor2018-12-21
NEUROTRONICS, INC.
Serenity Piezo Sensor, Serenity Thermocouple Sensor2018-12-21
NEUROTRONICS, INC.
Serenity Piezo Sensor, Serenity Thermocouple Sensor2018-12-21
NEUROTRONICS, INC.
Serenity Piezo Sensor, Serenity Thermocouple Sensor2018-12-21
NEUROTRONICS, INC.
Serenity Piezo Sensor, Serenity Thermocouple Sensor2018-12-21
NEUROTRONICS, INC.
Serenity RIP01 RIP Driver, Thorax, 249 Keyhole, 0.2m S413192018-12-10
NEUROTRONICS, INC.
Serenity RIP01 RIP Driver, Thorax, 1.5mm DIN, 0.2m S539552018-12-10
NEUROTRONICS, INC.
Serenity RIP01 RIP Driver, Abdomen, 249 Keyhole, 0.2m S509862018-12-10
NEUROTRONICS, INC.
Serenity RIP01 RIP Driver, Abdomen, 1.5mm DIN, 0.2m S751632018-12-10
NEUROTRONICS, INC.
Serenity RIP01 RIP Belt, Large - 32"-78" S348152018-12-10
NEUROTRONICS, INC.
Serenity RIP01 RIP Belt, Medium - 21"-45" S134212018-12-10
NEUROTRONICS, INC.
Serenity RIP01 RIP Belt, Small - 15"-27" S770382018-12-10
NEUROTRONICS, INC.
Serenity RIP01 RIP Driver, Thorax, 1.5mm DIN, 2.0m S215762018-12-10
NEUROTRONICS, INC.
Serenity RIP01 RIP Driver, Thorax, 1.5mm DIN, 0.6m S556382018-12-10
NEUROTRONICS, INC.
Serenity RIP01 RIP Driver, Abdomen, 249 Keyhole, 0.6m S391542018-12-10
NEUROTRONICS, INC.
Serenity RIP01 RIP Driver, Abdomen, 249 Keyhole, 2.0m S734262018-12-10
NEUROTRONICS, INC.
Serenity RIP01 RIP Driver, Thorax, 249 Keyhole, 2.0m S330592018-12-10
NEUROTRONICS, INC.
Serenity RIP01 RIP Driver, Thorax, 249 Keyhole, 0.6m S849962018-12-10
NEUROTRONICS, INC.
Serenity RIP01 RIP Driver, Abdomen, 1.5mm DIN, 2.0m S531072018-12-10
NEUROTRONICS, INC.
Serenity RIP01 RIP Driver, Abdomen, 1.5mm DIN, 0.6m S433592018-12-10
NEUROTRONICS, INC.
Serenity BP01 Body Position Sensor, 249 Keyhole, 2.0m S407122018-12-10
NEUROTRONICS, INC.
Serenity BP01 Body Position Sensor, 1.5mm DIN, 2.0m S297242018-12-10
NEUROTRONICS, INC.
Serenity BP01 Body Position Sensor, 3.5mm Mono, 2.0m S179262018-12-10
Neurotronics, Inc.
Serenity Piezo Sensor, Serenity Thermocouple Sensor2018-11-16
NEUROTRONICS, INC.
Serenity Body Position Sensor, Serenity RIP Sensors2018-10-30
NEUROTRONICS, INC.
USB DC Box 2018-07-06
NEUROTRONICS, INC.
Sphinx HB710 Head Box 2018-07-06
NEUROTRONICS, INC.
Sphinx CU710 Control Unit 2018-07-06
Neurotronics, Inc.
Serenity Body Position Sensor, Serenity RIP Sensors2018-07-02
NEUROTRONICS, INC.
Sphinx PMU700 Polysomnography Monitoring Unit 2018-03-29
NEUROTRONICS, INC.
Polysmith Sleep System, Model NTI75932017-03-09
NEUROTRONICS, INC.
Polysmith Sleep System, Model NTI75932017-03-09
NEUROTRONICS, INC.
Polysmith Sleep System, Model NTI75932017-03-09
NEUROTRONICS, INC.
Polysmith Sleep System, Model NTI75932017-03-09
Neurotronics, Inc.
Polysmith Sleep System, Model NTI75932017-01-19
NEUROTRONICS, INC.
Polysmith Sleep System NTI66002015-06-08
NEUROTRONICS, INC.
Polysmith Sleep System NTI66002015-06-08
NEUROTRONICS, INC.
Polysmith Sleep System NTI66002015-06-08
Neurotronics, Inc.
Polysmith Sleep System2015-02-18
NEUROTRONICS, INC.
Live View Panel (LVP)2013-08-15
NEUROTRONICS, INC.
Live View Panel (LVP)2013-08-15
NEUROTRONICS, INC.
Live View Panel (LVP)2013-08-15
NEUROTRONICS, INC.
Live View Panel (LVP)2013-08-15
NEUROTRONICS, INC.
LIVE VIEW PANEL (LVP)2013-08-09
NEUROTRONICS, INC.
Polysmith Sleep System2010-05-26
NEUROTRONICS, INC.
Nomad2010-05-26
NEUROTRONICS, INC.
Polysmith Sleep System2010-05-26
NEUROTRONICS, INC.
Nomad2010-05-26
NEUROTRONICS, INC.
Polysmith Sleep System2010-05-26
NEUROTRONICS, INC.
Nomad2010-05-26
NEUROTRONICS, INC.
NOMAD SLEEP SYSTEM RECORDER, MODEL PMU8002010-03-18
NEUROTRONICS, INC.
Sphinx2007-10-08
NEUROTRONICS, INC.
Polysmith Sleep System2007-10-08
NEUROTRONICS, INC.
Sphinx2007-10-08
NEUROTRONICS, INC.
Polysmith Sleep System2007-10-08
NEUROTRONICS, INC.
Sphinx2007-10-08
NEUROTRONICS, INC.
Polysmith Sleep System2007-10-08
NEUROTRONICS, INC.
POLYSMITH SLEEP SYSTEM, MODEL NTI54982007-05-09
NEUROTRONICS, INC.
echo2007-03-26
NEUROTRONICS, INC.
SIMONE2007-03-26
NEUROTRONICS, INC.
NEUROTRONICS POLYSOMNOGRAPHY SYSTEM 1011997-11-12

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