The following data is part of a premarket notification filed by Nuvasive, Inc. with the FDA for Modifcation To: Nuvasive Neurovision Emg Endotracheal Tube.
| Device ID | K094054 |
| 510k Number | K094054 |
| Device Name: | MODIFCATION TO: NUVASIVE NEUROVISION EMG ENDOTRACHEAL TUBE |
| Classification | Stimulator, Electrical, Evoked Response |
| Applicant | NUVASIVE, INC. 4545 TOWNE CENTRE COURT San Diego, CA 92121 |
| Contact | Sheila Bruschi |
| Correspondent | Sheila Bruschi NUVASIVE, INC. 4545 TOWNE CENTRE COURT San Diego, CA 92121 |
| Product Code | GWF |
| CFR Regulation Number | 882.1870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-12-31 |
| Decision Date | 2010-05-14 |
| Summary: | summary |