510(k) K083124
- Device
- NIM 3.0
- Applicant
- MEDTRONIC XOMED, INC.
- 510(k) number
- K083124
- Product code
- GWF
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2009-02-27
- Date received
- 2008-10-22
- Regulation
- 882.1870
- Classification name
- Stimulator, Electrical, Evoked Response
- Medical specialty
- Neurology
- Review panel
- Neurology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
- Source
- FDA openFDA 510(k) dataset plus migrated FDA.report data
Related Records
Applicant Contact
- Contact
- JAYME WILSON
- Address
- 6743 Southpoint Dr. N. Jacksonville FL US 32216 32216
FDA Registration Numbers
- 3001687738
- 3006639944
- 3001239363
- 2023374
- 3007770159
- 9613619
- 2183946
- 3023852420
- 3024996452
- 2032098
- 1824199
- 1052723
- 3012352782
- 3018708317
- 3004753785
- 2031093
- 3010209365
- 3003851073
- 2133772
- 8030229
- 3007713076
- 3017636737
- 1045254
- 2080783
- 3000279201
- 3012182497
- 3016438694
- 3009973336
- 3006128100
- 8043933
- 3003935342
- 1030489
- 3012263546
- 3030412764
- 3008102049
- 3010041499
- 2031966
- 3010611950
- 3017448360
- 1650946
- 1526534
- 1930870
- 3003631667
- 1835251
- 8021774
- 1056553
- 3003120897
- 3007611554
- 9612389
- 3020018
- 3010047454
- 3043543260
- 2027467
- 3009973505
- 9611896
- 9612501
- 2184161
- 1221763
- 1047843
- 1119189
- 3011790297
- 3030154814
- 3010123206
- 3014251656
- 1048735
- 2024311
- 3013501110
- 2183456
- 2530126
- 9615126
- 3003080184
- 3009050824
- 3019878714
- 3006783837
- 3006418479
- 3005706667
- 1526711
- 3007147067
- 3008773490
- 3005545216
- 3016852448
- 3007962724
- 9611252
- 3009144915
- 9612330
- 3007014520
- 3018094310
- 3009959868
- 3005581270
Source Documents
FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON
Related GUDID Devices
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00643169547087 | NIM® | MEDTRONIC XOMED, INC. | 2025-09-13 |
| 00763000835323 | NIM Neuro | MEDTRONIC XOMED, INC. | 2025-01-23 |
| 00763000835330 | NIM Neuro | MEDTRONIC XOMED, INC. | 2025-01-23 |
| 00763000200398 | NIM® | MEDTRONIC XOMED, INC. | 2024-05-12 |
| 00763000631598 | NIM™ | MEDTRONIC XOMED, INC. | 2022-07-04 |
| 00763000293055 | NIM | MEDTRONIC XOMED, INC. | 2020-10-03 |
| 00763000034092 | N/A | MEDTRONIC XOMED, INC. | 2019-06-10 |
| 00763000034085 | N/A | MEDTRONIC XOMED, INC. | 2019-04-04 |
| 00643169782402 | NA | MEDTRONIC XOMED, INC. | 2017-12-31 |
| 00643169782426 | NA | MEDTRONIC XOMED, INC. | 2017-12-31 |
| 00643169782433 | NA | MEDTRONIC XOMED, INC. | 2017-12-31 |
| 00643169783270 | NIM® | MEDTRONIC XOMED, INC. | 2017-12-31 |
| 00643169871038 | NIM-Neuro® | MEDTRONIC XOMED, INC. | 2017-03-30 |
| 00643169782549 | NIM-Response® | MEDTRONIC XOMED, INC. | 2017-02-10 |
| 00643169782556 | NIM-Neuro® | MEDTRONIC XOMED, INC. | 2017-02-10 |
| 00643169782440 | NIM-Response® | MEDTRONIC XOMED, INC. | 2017-02-10 |
| 00643169782471 | NIM® 3.0 | MEDTRONIC XOMED, INC. | 2017-02-10 |
| 00643169782464 | NIM-Neuro® | MEDTRONIC XOMED, INC. | 2017-02-10 |
| 00643169782457 | NIM-Pulse® | MEDTRONIC XOMED, INC. | 2017-02-10 |
| 00643169782495 | Nerve Integrity Monitor (NIM) 3.0 | MEDTRONIC XOMED, INC. | 2017-02-05 |
| 00643169782501 | Nerve Integrity Monitor (NIM) 3.0 | MEDTRONIC XOMED, INC. | 2017-02-05 |
| 00643169782532 | Nerve Integrity Monitor (NIM) 3.0 | MEDTRONIC XOMED, INC. | 2017-02-05 |
| 00643169782525 | Nerve Integrity Monitor (NIM) 3.0 | MEDTRONIC XOMED, INC. | 2017-02-05 |
| 00643169871014 | NIM-Response® | MEDTRONIC XOMED, INC. | 2016-12-12 |
| 00643169782518 | NIM-Neuro® | MEDTRONIC XOMED, INC. | 2016-11-27 |
| 00643169782488 | NIM-Response® | MEDTRONIC XOMED, INC. | 2016-11-27 |
| 00613994499646 | NIM-Neuro® | MEDTRONIC XOMED, INC. | 2016-09-29 |
| 00613994499653 | NIM-Neuro® | MEDTRONIC XOMED, INC. | 2016-09-29 |
| 00613994499714 | NIM-Response® | MEDTRONIC XOMED, INC. | 2016-09-29 |
| 00613994499660 | NIM® | MEDTRONIC XOMED, INC. | 2016-09-29 |
Legacy Summary
summary
FDA Review
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