510(k) K260455
- Device
- New Wave System
- Applicant
- Zeto, Inc.
- 510(k) number
- K260455
- Product code
- GWQ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2026-03-13
- Date received
- 2026-02-11
- Regulation
- 882.1400
- Classification name
- Full-Montage Standard Electroencephalograph
- Medical specialty
- Neurology
- Review panel
- Neurology
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- N
Related Records
Applicant Contact
- Contact
- Florian Strelzyk
- Address
- 5565 Centerview Dr. Suite 105 Raleigh NC US 27606 27606
FDA Registration Numbers
- 9710602
- 3008857629
- 9680891
- 2430863
- 9681860
- 3027256461
- 3013501110
- 3017666517
- 3019388613
- 3021826057
- 3010157426
- 1531052
- 8022257
- 3006125362
- 3018094310
- 3030154814
- 9615126
- 3018783526
- 3017970307
- 3013757456
- 3003851073
- 3009649442
- 3006315274
- 3021736577
- 3013596024
- 3013500228
- 3013679558
- 9610816
- 3013413442
- 3010900508
- 3007611554
- 3007323246
- 3005550372
- 3005877899
- 3008483389
- 3016852448
- 3006418479
- 3008058135
- 3008881376
- 3038189172
- 1530224
- 9710486
- 1045254
- 8020045
- 3004753785
- 3006177498
- 2023374
- 9612330
- 3020223448
- 3023272766
- 3009831876
- 3013671918
- 3029984080
- 3010762896
- 3004415095
- 3012359877
- 3007701713
- 1651104
- 9612389
- 1063925
- 2518422
- 3015491430
- 3016618143
- 3007962724
- 3008132398
- 3010536822
- 9611252
- 3027532607
- 3029922
- 3011353843
- 9617127
- 3012494290
- 3032109181
- 3011047165
- 3000126629
- 1219324
- 3004883754
- 3023707151
- 9613619
Source Documents
Other 510(k) Records For Product Code GWQ
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K233403 | Flexset System | Zeto, Inc. | 2024-04-30 |
| K231366 | Neuronaute Plus | Bioserenity Sas | 2023-11-09 |
| K221959 | Q21 | Neurofield, Inc. | 2023-08-31 |
| K231457 | SPARK Scan | Spark Neuro, Inc. | 2023-08-18 |
| K221963 | Cumulus Functional Neurophysiology Platform | Cumulus Neuroscience Limited | 2023-04-27 |
| K230073 | Okti | Compumedics Limited | 2023-02-09 |
| K223644 | Neuronaute with IceCap 2 & IceCap 2 Small | Bioserenity | 2023-01-12 |
| K220056 | iSyncWave | iMediSync, Inc. | 2022-08-10 |
| K212788 | Seer Home | Seer Medical Pty, Ltd. | 2022-06-16 |
| K213900 | WAVi SCAN EEG System and Accessories | Wavi Co. | 2022-05-06 |
| K193159 | NeuroAmp II, NeuroAmp II.5s | Corscience GmbH & Co. KG | 2020-12-30 |
| K202334 | Neuronaute | Bioserenity Sas | 2020-12-10 |
| K201819 | Cadwell Apollo System | Cadwell Industries, Inc. | 2020-09-29 |
| K191492 | Maxxi Position Sensor | Neurovirtual USA, Inc. | 2020-04-24 |
| K191868 | iCEWav Neuromonitoring Platform | Ice Neurosystems, Inc. | 2020-03-31 |