510(k) K180232
- Device
- DAEHAN Disposable CUP Electrodes
- Applicant
- Daehan Medical Systems Co., Ltd.
- 510(k) number
- K180232
- Product code
- GXY
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2019-04-03
- Date received
- 2018-01-29
- 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
- Da Roo Ha
- Address
- 250 Okgucheondong-Ro Siheung-City KR 15084 15084
FDA Registration Numbers#
- 3023237645
- 1045254
- 3019878714
- 3010852191
- 9616494
- 3005663471
- 9616086
- 3016852448
- 3021192567
- 1526534
- 3010402752
- 9611558
- 3009499478
- 3027329006
- 3016674095
- 1930027
- 8030245
- 3008806011
- 3008892509
- 3008202779
- 2183164
- 3003573572
- 2027467
- 3022954003
- 8022257
- 3036833452
- 3013069546
- 3011534533
- 3011077581
- 2031094
- 3004558433
- 3019388613
- 3007689716
- 3017970307
- 3005698910
- 3005190268
- 3008312728
- 3012840029
- 3031464228
- 3006850006
- 3003749270
- 1063285
- 3013378804
- 3011466827
- 3014579161
- 1056553
- 3002893037
- 3027256461
- 9710582
- 3028172072
- 3008048783
- 3012316249
- 3008657519
- 2939821
- 3013298431
- 3038195193
- 3000947648
- 3013757456
- 3003072803
- 3019822804
- 1528161
- 3008255748
- 3004146401
- 9710051
- 3004426795
- 1417592
- 3006258094
- 3011310592
- 3007603826
- 3017210488
- 3012321270
- 9612389
- 3007748793
- 3019865183
- 1047843
- 3008525454
- 1060680
- 8022077
- 3009555600
Source Documents#
Other 510(k) Records For Product Code GXY #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| 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 |