The following data is part of a premarket notification filed by Medtronic Xomed, Inc. with the FDA for Next Gen Emg Endotracheal Tube.
| Device ID | K112686 |
| 510k Number | K112686 |
| Device Name: | NEXT GEN EMG ENDOTRACHEAL TUBE |
| Classification | Stimulator, Nerve |
| Applicant | MEDTRONIC XOMED, INC. 6743 SOUTHPOINT DR. NORTH Jacksonville, FL 32216 |
| Contact | Marek Pawlowski |
| Correspondent | Marek Pawlowski MEDTRONIC XOMED, INC. 6743 SOUTHPOINT DR. NORTH Jacksonville, FL 32216 |
| Product Code | ETN |
| CFR Regulation Number | 874.1820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-09-15 |
| Decision Date | 2012-06-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20643169060863 | K112686 | 000 |
| 00643169782600 | K112686 | 000 |
| 00643169782594 | K112686 | 000 |
| 00643169782587 | K112686 | 000 |
| 00643169782570 | K112686 | 000 |
| 20763000041506 | K112686 | 000 |
| 00763000033972 | K112686 | 000 |
| 00763000033965 | K112686 | 000 |
| 00763000033958 | K112686 | 000 |
| 20763000041544 | K112686 | 000 |
| 20763000041537 | K112686 | 000 |
| 20763000041520 | K112686 | 000 |
| 20763000041513 | K112686 | 000 |
| 00763000033941 | K112686 | 000 |
| 00643169782617 | K112686 | 000 |
| 20643169782628 | K112686 | 000 |
| 20643169060856 | K112686 | 000 |
| 20643169060849 | K112686 | 000 |
| 20643169060832 | K112686 | 000 |
| 20643169060825 | K112686 | 000 |
| 00643169060814 | K112686 | 000 |
| 00643169060807 | K112686 | 000 |
| 00643169060791 | K112686 | 000 |
| 00643169060784 | K112686 | 000 |
| 00643169060777 | K112686 | 000 |
| 20643169782666 | K112686 | 000 |
| 20643169782659 | K112686 | 000 |
| 20643169782642 | K112686 | 000 |
| 20643169782635 | K112686 | 000 |
| 00763000033934 | K112686 | 000 |