The following data is part of a premarket notification filed by Carefusion 209, Inc. with the FDA for Carefusion Nicolet Edx.
| Device ID | K112052 |
| 510k Number | K112052 |
| Device Name: | CAREFUSION NICOLET EDX |
| Classification | Stimulator, Electrical, Evoked Response |
| Applicant | CAREFUSION 209, INC. 1850 Deming Way Middleton, WI 53562 |
| Contact | Robert Burdge |
| Correspondent | Robert Burdge 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-07-18 |
| Decision Date | 2012-03-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00382830041560 | K112052 | 000 |
| 00382830033848 | K112052 | 000 |
| 00382830033831 | K112052 | 000 |
| 00382830033824 | K112052 | 000 |
| 00382830033817 | K112052 | 000 |
| 00382830032162 | K112052 | 000 |
| 00382830031813 | K112052 | 000 |
| 00382830031509 | K112052 | 000 |
| 00382830042369 | K112052 | 000 |
| 00382830061650 | K112052 | 000 |
| 00382830033893 | K112052 | 000 |
| 00382830037044 | K112052 | 000 |
| 00382830037198 | K112052 | 000 |
| 00382830038478 | K112052 | 000 |
| 00382830037648 | K112052 | 000 |
| 00382830037631 | K112052 | 000 |
| 00382830037457 | K112052 | 000 |
| 00382830037433 | K112052 | 000 |
| 00382830037341 | K112052 | 000 |
| 00382830037327 | K112052 | 000 |
| 00382830037303 | K112052 | 000 |
| 00382830037280 | K112052 | 000 |
| 00382830061643 | K112052 | 000 |