The following data is part of a premarket notification filed by Baxano, Inc. with the FDA for Baxano Neuro Check Device.
| Device ID | K092729 |
| 510k Number | K092729 |
| Device Name: | BAXANO NEURO CHECK DEVICE |
| Classification | Stimulator, Nerve |
| Applicant | BAXANO, INC. 1171 BARROILHET AVENUE Hillsborough, CA 94010 -6577 |
| Contact | Cindy Domecus |
| Correspondent | Cindy Domecus BAXANO, INC. 1171 BARROILHET AVENUE Hillsborough, CA 94010 -6577 |
| Product Code | ETN |
| CFR Regulation Number | 874.1820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-09-04 |
| Decision Date | 2009-10-02 |
| Summary: | summary |