NomadAir PMU810
Neurotronics, Inc.
NEUROTRONICS, LLC
FDA Registration(s)
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 1063925 | 3002459124 | NEUROTRONICS, LLC | 1 | N | 2026-01-01 | 13800 Tech City Circle, Suite 400 Alachua FL US 32615 |
Registered Device Listings
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 108700 | 1375785968 | K251480 | PV01 PVDF Effort Sensor | SFK | 2025-08-29 |
| 108700 | 1643687557 | K220631 | NomadAir PMU810 | GWL | 2022-07-15 |
| 108700 | 1100719275 | K181709 | Serenity Piezo Sensor, Serenity Thermocouple Sensor | OLV | 2018-11-16 |
| 108700 | 1539092049 | K173868 | Serenity Body Position Sensor, Serenity RIP Sensors | OLV | 2018-07-02 |
| 108700 | 1060612370 | K161650 | Polysmith Sleep System, Model NTI7593 | OLV | 2017-01-19 |
| 108700 | 1245505659 | K142774 | Polysmith Sleep System | OLV | 2015-02-18 |
| 108700 | 1893773946 | K131415 | LIVE VIEW PANEL (LVP) | OLV | 2013-08-09 |
| 108700 | 1446410004 | K092699 | NOMAD SLEEP SYSTEM RECORDER, MODEL PMU800 | GWL | 2010-03-18 |
| 108700 | 1075469671 | K062943 | POLYSMITH SLEEP SYSTEM, MODEL NTI5498 | OLZ | 2007-05-09 |
| 108700 | 1508639145 |
Product Codes Associated With Registrations
PMN
Serenity Piezo Sensor, Serenity Thermocouple Sensor
Neurotronics, Inc.
Serenity Body Position Sensor, Serenity RIP Sensors
Neurotronics, Inc.
Polysmith Sleep System, Model NTI7593
Neurotronics, Inc.
Polysmith Sleep System
Neurotronics, Inc.
LIVE VIEW PANEL (LVP)
NEUROTRONICS, INC.
NOMAD SLEEP SYSTEM RECORDER, MODEL PMU800
NEUROTRONICS, INC.
POLYSMITH SLEEP SYSTEM, MODEL NTI5498
NEUROTRONICS, INC.
NEUROTRONICS POLYSOMNOGRAPHY SYSTEM 101
NEUROTRONICS, INC.
GUDID
Polysmith - 12.3
2025-09-23
Live View Panel Pro Version 2.0 - 2.0
2024-05-09
Echo Polysomnography Playback Unit - ECHO320
2023-06-07
NomadAir PMU810 Portable Recorder - PMU810
2022-12-27
NomadAir PMU810 RIP Belt, Small - PMU810
2022-12-27
NomadAir PMU810 RIP Belt, Medium - PMU810
2022-12-27
NomadAir PMU810 RIP Belt, Large - PMU810
2022-12-27
Polysmith Version 12.2 - 12.2
2022-12-28
Polysmith Version 12.0 - 12.0
2020-04-01
Live View Panel Version 1.3 - 1.3
2016-09-22
Live View Panel Version 1.4 - 1.4
2017-10-05
Polysmith Version 11.0 - 11.0
2017-03-10
Polysmith Version 9.0 - 9.0
2016-09-22
Polysmith Version 10.0 - 10.0
2016-09-22
Nomad PMU800 Portable Recorder (USB) - PMU800
2019-05-01
Serenity PZ01 Piezo Sensor, 1.5mm DIN, 3.0m - PZ01
2019-05-01
Serenity PZ01 Piezo Sensor, 249 Keyhole, 3.0m - PZ01
2019-05-01
Nomad PMU800 Portable Recorder - PMU800
2016-09-22
Serenity TH01 Thermocouple Sensor, 249 Keyhole, 2.0m - TH01
2018-12-27
Serenity PZ01 Piezo Sensor, 1.5mm DIN, 2.0m - PZ01
2018-12-27
Serenity PZ01 Piezo Sensor, 1.5mm DIN, 0.6m - PZ01
2018-12-27
Serenity PZ01 Piezo Sensor, 249 Keyhole, 2.0m - PZ01
2018-12-27
Serenity PZ01 Piezo Sensor, 249 Keyhole, 0.6m - PZ01
2018-12-27
Serenity TH01 Thermocouple Sensor, 1.5mm DIN, 0.6m - TH01
2018-12-27
Serenity TH01 Thermocouple Sensor, 1.5mm DIN, 1.2m - TH01
2018-12-27
Serenity TH01 Thermocouple Sensor, 1.5mm DIN, 2.0m - TH01
2018-12-27
Serenity TH01 Thermocouple Sensor, 249 Keyhole, 0.6m - TH01
2018-12-27
Serenity TH01 Thermocouple Sensor w/ Hanger, 1.5mm DIN, 0.6m - TH01
2018-12-27
Serenity TH01 Thermocouple Sensor w/ Hanger, 1.5mm DIN, 1.2m - TH01
2018-12-27
Serenity TH01 Thermocouple Sensor w/ Hanger, 1.5mm DIN, 2.0m - TH01
2018-12-27
Serenity TH01 Thermocouple Sensor w/ Hanger, 249 Keyhole, 0.6m - TH01
2018-12-27
Serenity TH01 Thermocouple Sensor w/ Hanger, 249 Keyhole, 2.0m - TH01
2018-12-27
Serenity RIP01 RIP Driver, Abdomen, 249 Keyhole, 2.0m - RIP01
2018-11-08
Serenity RIP01 RIP Driver, Thorax, 249 Keyhole, 0.2m - RIP01
2018-11-08
Serenity RIP01 RIP Driver, Thorax, 1.5mm DIN, 0.2m - RIP01
2018-11-08
Serenity RIP01 RIP Driver, Abdomen, 249 Keyhole, 0.2m - RIP01
2018-11-08
Serenity RIP01 RIP Driver, Abdomen, 1.5mm DIN, 0.2m - RIP01
2018-11-08
Serenity RIP01 RIP Belt, Large - 32"-78" - RIP01
2018-11-08
Serenity RIP01 RIP Belt, Medium - 21"-45" - RIP01
2018-11-08
Serenity RIP01 RIP Belt, Small - 15"-27" - RIP01
2018-11-08