The following data is part of a premarket notification filed by Baxano, Inc. with the FDA for Neuro Check Device With Io-flex Wire.
| Device ID | K110696 |
| 510k Number | K110696 |
| Device Name: | NEURO CHECK DEVICE WITH IO-FLEX WIRE |
| Classification | Stimulator, Nerve |
| Applicant | BAXANO, INC. 655 RIVER OAKS PKWY San Jose, CA 95134 |
| Contact | Edward Sinclair |
| Correspondent | Edward Sinclair BAXANO, INC. 655 RIVER OAKS PKWY San Jose, CA 95134 |
| Product Code | ETN |
| CFR Regulation Number | 874.1820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-03-14 |
| Decision Date | 2011-07-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840916103903 | K110696 | 000 |
| 00840916103804 | K110696 | 000 |