The following data is part of a premarket notification filed by Nuvasive, Incorporated with the FDA for Nuvasive Emg Endotracheal Tube.
| Device ID | K133530 |
| 510k Number | K133530 |
| Device Name: | NUVASIVE EMG ENDOTRACHEAL TUBE |
| Classification | Neurosurgical Nerve Locator |
| Applicant | NUVASIVE, INCORPORATED 7475 LUSK BLVD San Diego, CA 92121 |
| Contact | Jeremy Markovich |
| Correspondent | Jeremy Markovich NUVASIVE, INCORPORATED 7475 LUSK BLVD San Diego, CA 92121 |
| Product Code | PDQ |
| Subsequent Product Code | BSK |
| Subsequent Product Code | BTR |
| CFR Regulation Number | 874.1820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-11-15 |
| Decision Date | 2014-05-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00887517161390 | K133530 | 000 |
| 00887517161383 | K133530 | 000 |
| 00887517055644 | K133530 | 000 |
| 00887517055637 | K133530 | 000 |
| 00887517102560 | K133530 | 000 |
| 00887517163233 | K133530 | 000 |
| 00887517163226 | K133530 | 000 |
| 00887517163219 | K133530 | 000 |