510(k) K043009
- Device
- BRAINET KIT
- Applicant
- JORDAN NEUROSCIENCE, INC.
- 510(k) number
- K043009
- Product code
- GXY
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2005-01-12
- Date received
- 2004-11-01
- Regulation
- 882.1320
- Classification name
- Electrode, Cutaneous
- Medical specialty
- Neurology
- Review panel
- Neurology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- ANNE PERRY
- Address
- 399 E. Highland Ave., Suite 316 San Bernardino CA US 92404 92404
FDA Registration Numbers#
- 3005581270
- 9681860
- 3011307234
- 1417592
- 3045752480
- 3011267903
- 8022257
- 3017210488
- 8022890
- 3005663471
- 9612330
- 3004040397
- 3043013796
- 3006697681
- 3031464228
- 3011353843
- 3027256461
- 1721293
- 3011905669
- 9610105
- 8020045
- 3007748793
- 3030151584
- 3015429360
- 3004415095
- 8010720
- 3010813366
- 3002923871
- 1626185
- 3007836437
- 3005190268
- 1223925
- 3006153348
- 3008048783
- 3018940143
- 2000004234
- 3030597665
- 3008806011
- 3013596024
- 2245302
- 9617486
- 3011191255
- 3010611950
- 3003935342
- 3024892936
- 3029973920
- 3043226252
- 3008008477
- 3003971136
- 3001373226
- 3010605876
- 3014027738
- 2135339
- 3006258094
- 2085491
- 9710051
- 3011466827
- 3007502541
- 2031094
- 3012840029
- 3020018
- 3013378804
- 1420295
- 3004839404
- 3003573572
- 3027718340
- 3008507279
- 2024024
- 3033509895
- 3012134907
- 3017450375
- 3017953405
- 1911273
- 3008525454
- 3022631685
- 8044004
- 3011077581
- 3025186177
- 3011534533
Source Documents#
Other 510(k) Records For Product Code GXY #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K262654 | Dexus Prosthetic System (MSL2, MSR2) | Zhejiang Qiangnao Technology Co.,Ltd | 2026-08-27 |
| K260578 | Ambu® NeurolineTM Cup MRI/CT (Models 72704/21US, 72704/23US, 72704/25US, 72704/27US) Ambu® NeurolineTM Cup MRI/CT-set (Models 72704/21-1010US, 72704/21-1010US, 72704/23-1010US, 72704/25-1010US, 72704/27-1010US) Ambu® NeurolineTM Cup MRI/CT-mini set (Models 72704/21-0301US, 72704/23-0301US, 72704/25-0301US, 72704/27-0301US) | Ambu A/S | 2026-07-14 |
| K261442 | Charlotte ACC25 Surface Electrode Array; Charlotte ACC25 Reusable Surface Electrode Array | Cadwell Industries, Inc. | 2026-06-26 |
| K261522 | BioWave BioWraps | Biowave Corporation | 2026-06-03 |
| 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 |
| K260453 | Remote Wave Electrode (AE03-50); Remote Wave Electrode (AE03-60) | Bionit Labs Srl | 2026-03-12 |
| 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 |
Legacy Summary#
summary
FDA Review#
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