510(k) K203079
- Device
- MR Conditional Sticky Pad Electrode
- Applicant
- Rhythmlink International, LLC
- 510(k) number
- K203079
- Product code
- GXY
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2021-02-09
- Date received
- 2020-10-13
- 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
Related Records
Applicant Contact
- Contact
- Gabriel Orsinger
- Address
- 1140 First St. S. Columbia SC US 29209 29209
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
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|---|---|---|---|
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| 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 |