The following data is part of a premarket notification filed by Carefusion 209, Inc. with the FDA for Carefusion Nicolet Edx.
| Device ID | K120979 |
| 510k Number | K120979 |
| Device Name: | CAREFUSION NICOLET EDX |
| Classification | Stimulator, Electrical, Evoked Response |
| Applicant | CAREFUSION 209, INC. 1850 Deming Way Middleton, WI 53562 |
| Contact | Curtis Truesdale |
| Correspondent | Curtis Truesdale CAREFUSION 209, INC. 1850 Deming Way Middleton, WI 53562 |
| Product Code | GWF |
| Subsequent Product Code | GWE |
| Subsequent Product Code | GWJ |
| Subsequent Product Code | GZP |
| Subsequent Product Code | IKN |
| Subsequent Product Code | JXE |
| Subsequent Product Code | OLT |
| CFR Regulation Number | 882.1870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-04-02 |
| Decision Date | 2012-04-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00382830038034 | K120979 | 000 |
| 00382830058285 | K120979 | 000 |
| 00382830058308 | K120979 | 000 |
| 00382830058391 | K120979 | 000 |
| 00382830058407 | K120979 | 000 |
| 00382830058414 | K120979 | 000 |
| 00382830058438 | K120979 | 000 |
| 00382830058421 | K120979 | 000 |
| 00382830058445 | K120979 | 000 |
| 00382830031493 | K120979 | 000 |
| 00382830033879 | K120979 | 000 |
| 00382830037969 | K120979 | 000 |
| 00382830038003 | K120979 | 000 |
| 00382830038027 | K120979 | 000 |
| 00382830058278 | K120979 | 000 |