510(k) K182112
- Device
- Sense System With IBT Electrodes
- Applicant
- Infinite Biomedical Technologies, LLC
- 510(k) number
- K182112
- Product code
- GXY
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2018-10-05
- Date received
- 2018-08-06
- 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
- Rahul Kaliki
- Address
- 8 Market Pl. Suite 500 Baltimore MD US 21202 21202
FDA Registration Numbers#
- 3011905669
- 1052723
- 3005698910
- 3007048259
- 3017264244
- 2027467
- 3005955744
- 3017970307
- 3013298431
- 9613619
- 3014659326
- 1528161
- 3014579161
- 3006850006
- 3031464228
- 3030978471
- 9616494
- 1320894
- 3008657519
- 3009555600
- 3005190268
- 2013558
- 3005621440
- 3046649655
- 1450057
- 3015531976
- 3014692331
- 3012321270
- 3016674095
- 3010632563
- 1045254
- 3006697681
- 3006258094
- 3007603826
- 2025066
- 3030151584
- 3014027738
- 3006315274
- 3025186177
- 3020018
- 2183164
- 3021192567
- 3006153348
- 3008892509
- 3009831876
- 3018940143
- 9710376
- 1526534
- 3019878714
- 9610105
- 3009156722
- 2025694
- 3006551156
- 9616877
- 1930027
- 3008716327
- 3007028037
- 3003446042
- 3008255748
- 2936999
- 3021826057
- 1063285
- 3002923871
- 1067162
- 3013500228
- 2135339
- 3008806011
- 3011353843
- 3008525454
- 3005463575
- 1047843
- 3012316249
- 3045752480
- 9612243
- 9612389
- 3008273892
- 3015060202
- 9612330
- 9710582
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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