Company ยท US
Neurotronics, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1997 to 2026. Name variants (Inc, Corp, punctuation) are merged.
11510(k) clearances (1 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 9, 2026 | K261521 | Sleep Analysis Module Neurotronics, LLC | OLZ |
| Aug 29, 2025 | K251480 | PV01 PVDF Effort Sensor Neurotronics, LLC | SFK |
| Jul 15, 2022 | K220631 | NomadAir PMU810 Neurotronics, Inc. | GWL |
| Nov 16, 2018 | K181709 | Serenity Piezo Sensor, Serenity Thermocouple Sensor Neurotronics, Inc. | OLV |
| Jul 2, 2018 | K173868 | Serenity Body Position Sensor, Serenity RIP Sensors Neurotronics, Inc. | OLV |
| Jan 19, 2017 | K161650 | Polysmith Sleep System, Model NTI7593 Neurotronics, Inc. | OLV |
| Feb 18, 2015 | K142774 | Polysmith Sleep System Neurotronics, Inc. | OLV |
| Aug 9, 2013 | K131415 | LIVE VIEW PANEL (LVP) Neurotronics, Inc. | OLV |
| Mar 18, 2010 | K092699 | NOMAD SLEEP SYSTEM RECORDER, MODEL PMU800 Neurotronics, Inc. | GWL |
| May 9, 2007 | K062943 | POLYSMITH SLEEP SYSTEM, MODEL NTI5498 Neurotronics, Inc. | OLZ |
| Nov 12, 1997 | K971803 | NEUROTRONICS POLYSOMNOGRAPHY SYSTEM 101 Neurotronics, Inc. | MNR |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||