510(k) K260453
- Device
- Remote Wave Electrode (AE03-50); Remote Wave Electrode (AE03-60)
- Applicant
- Bionit Labs Srl
- 510(k) number
- K260453
- Product code
- GXY
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2026-03-12
- Date received
- 2026-02-11
- Regulation
- 882.1320
- Classification name
- Electrode, Cutaneous
- Medical specialty
- Neurology
- Review panel
- Neurology
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Aventaggiato Matteo
- Address
- Via Cracovia 1 Soleto IT 73010 73010
FDA Registration Numbers#
- 9710602
- 3020494684
- 1423537
- 9616494
- 9681860
- 2245302
- 2024024
- 3006636961
- 3027718340
- 3027256461
- 1056553
- 1721293
- 3008716327
- 3019388613
- 3021826057
- 3015531976
- 3033509895
- 8022077
- 3009351773
- 1644243
- 1423662
- 3011310592
- 3007710601
- 3028172072
- 3022631685
- 3005511941
- 8022257
- 3010805941
- 3001373226
- 3009499478
- 9616877
- 3010852191
- 2183164
- 3004920696
- 3008312728
- 3026753375
- 3003749270
- 3006125362
- 3030978471
- 3024892936
- 3030151584
- 3004753827
- 1047843
- 3018070844
- 3018094310
- 3006626283
- 3006697681
- 9681377
- 2022388
- 3008048783
- 3029973920
- 3017970307
- 3004786509
- 3009171251
- 8022189
- 3014649088
- 3013757456
- 3003851073
- 3006258094
- 3013957847
- 3019865183
- 3017697481
- 3017887928
- 3021192567
- 1055808
- 3006315274
- 3006850006
- 3005581220
- 3013596024
- 3013500228
- 3013671142
- 3011412151
- 3002893037
- 3004040397
- 3011534533
- 3013069546
- 1063285
- 1522166
- 3023164
Source Documents#
Other 510(k) Records For Product Code GXY#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253237 | Elde Medical Electrodes (T5/ 5 cm x 5cm electrode T10/ 5 cm x 10cm electrode) | Elde Medikal Sanayi ve Ticaret Anonim Sirketi | 2026-05-08 |
| K254183 | MR Conditional Cup Electrodes | Technomed Europe | 2026-05-07 |
| K252439 | Tutamen Self Adhesive Electrodes | Dongguan Tutamen Metalwork Co., Ltd. | 2026-05-01 |
| K253256 | myosmart. (13E522); myosmart.cuff (757M20-2); connectgrip. (560X27-1); myosmart trial kit (642V64=T) | Otto Bock Healthcare Products GmbH | 2026-04-22 |
| K260363 | Ceribell Brain Monitor Headband | Ceribell, Inc. | 2026-04-03 |
| K254033 | Ceribell Instant EEG Headset | Ceribell, Inc. | 2026-02-09 |
| K251381 | Ceribell Instant EEG Headcap (Small: C251, Medium: C252) | Ceribell, Inc. | 2025-10-31 |
| K250841 | Electrotherapy Electrodes | Baisheng Medical Co., Ltd. | 2025-08-13 |
| K243788 | IceCap product line | Bioserenity Medical Devices Group | 2025-03-13 |
| K243243 | Delphi MCS Electrode Cap | Quantalx Neuroscience, Ltd. | 2025-02-06 |
| K241512 | Electrode Pad | Shenzhen Deliduo Medical Technology Co.,Ltd | 2025-01-15 |
| K242326 | Wave Electrode (AE02-60); Wave Electrode (AE02-50) | Bionit Labs Srl | 2025-01-02 |
| K241160 | CAIs Sensor (CAIs-001) | Brainu Co., Ltd. | 2024-12-13 |
| K240575 | WaveGuard Net EEG Cap (NA-245, NA-255, NA-261, NA-265, NA-271, NA-281) | Eemagine Medical Imaging Solutions GmbH | 2024-11-25 |
| K242346 | Grass® MR Conditional/CT Cup Electrodes | Natus Manufacturing Limited | 2024-08-29 |