510(k) K112686
- Device
- NEXT GEN EMG ENDOTRACHEAL TUBE
- Applicant
- MEDTRONIC XOMED, INC.
- 510(k) number
- K112686
- Product code
- ETN
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2012-06-27
- Date received
- 2011-09-15
- Regulation
- 874.1820
- Classification name
- Stimulator, Nerve
- Medical specialty
- Ear Nose & Throat
- Review panel
- Ear Nose & Throat
- 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
- MAREK PAWLOWSKI
- Address
- 6743 Southpoint Dr. N. Jacksonville FL US 32216 32216
FDA Registration Numbers
- 1000200989
- 3013480096
- 9710376
- 1412854
- 3006639944
- 3020706315
- 2134470
- 3010057495
- 1052728
- 3004464325
- 2132111
- 3007770159
- 2183744
- 3010041430
- 2183946
- 3023852420
- 1824199
- 2032098
- 3004598644
- 1052723
- 1833920
- 3025603301
- 3004753785
- 2031093
- 3011050570
- 3010209365
- 2246552
- 3003851073
- 2133772
- 1721676
- 2532027
- 3007713076
- 1064858
- 3017210488
- 3009103001
- 3017636737
- 3011534533
- 1045254
- 9611390
- 3031284747
- 3042364673
- 3016438694
- 3009973336
- 3006128100
- 3014279513
- 3003935342
- 1030489
- 3012263546
- 3030412764
- 3008102049
- 2031966
- 3010611950
- 3010120135
- 3009417901
- 3008573567
- 3013485140
- 3004024955
- 3000270450
- 1928237
- 1526534
- 1319639
- 1828288
- 9680837
- 1930870
- 1061927
- 8021774
- 1056553
- 3009888740
- 3006697681
- 3003477135
- 3023164
- 3003120897
- 3021632375
- 3020018
- 3007207906
- 3005497913
- 1218017
- 3010047454
- 2134947
Source Documents
FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON
Related GUDID Devices
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00763000033934 | NIM TriVantage® | MEDTRONIC XOMED, INC. | 2020-02-29 |
| 00763000033941 | NIM TriVantage® | MEDTRONIC XOMED, INC. | 2020-02-29 |
| 20763000041513 | NIM TriVantage® | MEDTRONIC XOMED, INC. | 2020-02-29 |
| 20763000041520 | NIM TriVantage® | MEDTRONIC XOMED, INC. | 2020-02-29 |
| 20763000041537 | NIM TriVantage® | MEDTRONIC XOMED, INC. | 2020-02-29 |
| 20763000041544 | NIM TriVantage® | MEDTRONIC XOMED, INC. | 2020-02-29 |
| 00763000033958 | NIM TriVantage® | MEDTRONIC XOMED, INC. | 2020-02-15 |
| 00763000033965 | NIM TriVantage® | MEDTRONIC XOMED, INC. | 2020-02-15 |
| 00763000033972 | NIM TriVantage® | MEDTRONIC XOMED, INC. | 2020-02-15 |
| 20763000041506 | NIM TriVantage® | MEDTRONIC XOMED, INC. | 2020-02-15 |
| 00643169782617 | NIM Trivantage® | MEDTRONIC XOMED, INC. | 2016-11-12 |
| 00643169782570 | NIM Trivantage® | MEDTRONIC XOMED, INC. | 2016-11-12 |
| 00643169782587 | NIM Trivantage® | MEDTRONIC XOMED, INC. | 2016-11-12 |
| 00643169782594 | NIM Trivantage® | MEDTRONIC XOMED, INC. | 2016-11-12 |
| 00643169782600 | NIM Trivantage® | MEDTRONIC XOMED, INC. | 2016-11-12 |
| 20643169782628 | NIM Trivantage® | MEDTRONIC XOMED, INC. | 2016-11-12 |
| 20643169782635 | NIM Trivantage® | MEDTRONIC XOMED, INC. | 2016-11-12 |
| 20643169782642 | NIM Trivantage® | MEDTRONIC XOMED, INC. | 2016-11-12 |
| 20643169782659 | NIM Trivantage® | MEDTRONIC XOMED, INC. | 2016-11-12 |
| 20643169782666 | NIM Trivantage® | MEDTRONIC XOMED, INC. | 2016-11-12 |
| 00643169060777 | NIM TriVantage™ | MEDTRONIC XOMED, INC. | 2016-04-23 |
| 00643169060784 | NIM TriVantage™ | MEDTRONIC XOMED, INC. | 2016-04-23 |
| 00643169060791 | NIM TriVantage™ | MEDTRONIC XOMED, INC. | 2016-04-23 |
| 00643169060807 | NIM TriVantage™ | MEDTRONIC XOMED, INC. | 2016-04-23 |
| 00643169060814 | NIM TriVantage™ | MEDTRONIC XOMED, INC. | 2016-04-23 |
| 20643169060863 | TriVantage™ | MEDTRONIC XOMED, INC. | 2016-04-22 |
| 20643169060825 | TriVantage™ | MEDTRONIC XOMED, INC. | 2016-04-22 |
| 20643169060832 | TriVantage™ | MEDTRONIC XOMED, INC. | 2016-04-22 |
| 20643169060849 | TriVantage™ | MEDTRONIC XOMED, INC. | 2016-04-22 |
| 20643169060856 | TriVantage™ | MEDTRONIC XOMED, INC. | 2016-04-22 |
Legacy Summary
summary
FDA Review
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