510(k) K092477
- Device
- NEUROSENSE MONITORING SYSTEM, MODEL NS-701
- Applicant
- NEUROWAVE SYSTEMS, INC.
- 510(k) number
- K092477
- Product code
- OMC
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2010-10-29
- Date received
- 2009-08-12
- Regulation
- 882.1400
- Classification name
- Reduced- Montage Standard Electroencephalograph
- Medical specialty
- Neurology
- Review panel
- Neurology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- TRACIE CAPOZZIO
- Address
- 2490 Lee Blvd., Suite 300 Cleveland Heights OH US 44118 44118
FDA Registration Numbers#
- 9612330
- 1930027
- 3004762958
- 3043014934
- 3011184129
- 3005783425
- 9612389
- 9613619
- 8030229
- 3009247326
- 3009077524
- 3018238599
- 3009391672
- 3038138206
- 3013501110
- 8044004
- 9611252
- 3024892936
- 3016701404
- 3013500228
- 3010157426
- 3000126629
- 3012528160
- 3008657519
- 3008202779
- 1529102
- 9610816
- 3009831876
- 2221819
- 3004964738
- 1651104
- 3032109181
- 3027256461
- 3008729547
- 3016674095
- 3010611950
- 3007323246
- 3013679558
- 9610105
- 3033509895
- 3023164
- 3009156722
- 3013596024
- 1650946
- 3001570235
- 3004415095
- 3009770872
- 3012359877
- 3010806878
- 9710602
- 3019388613
- 3033715634
- 3013755083
- 3004203820
- 3008483389
- 3011353843
- 3020018
- 3007603826
- 3038281851
- 3030978471
- 3005877899
- 3007611554
- 8022257
- 3014461810
- 3016852448
- 3008255748
- 2080783
- 3013671918
- 3014692331
- 3008657524
Source Documents#
Other 510(k) Records For Product Code OMC #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K251550 | NX01 (NX01) | Naox Technologies Sas | 2025-11-25 |
| K251726 | SignalNED System (Model RE) | Forest Devices, Inc. | 2025-09-03 |
| K243185 | REMI Remote EEG Monitoring System | Epitel | 2025-03-21 |
| K242930 | Natus BrainWatch System | Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) | 2024-11-19 |
| K232779 | QUEX ED; QUEX S | Qx World, Ltd. | 2024-10-11 |
| K242306 | SignalNED System (Model RE) | Forest Devices, Inc. | 2024-09-04 |
| K230933 | REMI Remote EEG Monitoring System | Epitel, Inc. | 2023-06-30 |
| K223628 | NEBA® Compact EEG2R Mobile Headset | Neba Health, LLC | 2023-03-02 |
| K221563 | Neurosteer EEG Recorder | Neurosteer, Inc. | 2022-10-24 |
| K203827 | REMI | Epitel, Inc. | 2021-03-29 |
| K192549 | Byteflies Kit | Byteflies NV | 2020-06-22 |
| K183529 | AE-120A EEG Head Set | Nihon Kohden Corporation | 2019-03-19 |
| K170363 | Ceribell Pocket EEG Device | Ceribell, Inc. | 2017-05-08 |
| K152040 | X8 System - Sleep Profiler (SP40), X8 System - Sleep Profiler PSG2 (SP29), X8 System - Stat X8 (XS29) | Advanced Brain Monitoring, Inc. | 2015-10-30 |
| K131944 | IEEG | Jordan Neuroscience, Inc. | 2014-04-10 |
Legacy Summary#
summary
FDA Review#
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