The following data is part of a premarket notification filed by Nihon Kohden Corp. with the FDA for Meb-2300a Neuropack Evoked Potential And Emg Measuring System.
| Device ID | K120397 |
| 510k Number | K120397 |
| Device Name: | MEB-2300A NEUROPACK EVOKED POTENTIAL AND EMG MEASURING SYSTEM |
| Classification | Stimulator, Electrical, Evoked Response |
| Applicant | NIHON KOHDEN CORP. 90 ICON STREET Foothill Ranch, CA 92610 |
| Contact | Steve Geerdes |
| Correspondent | Steve Geerdes NIHON KOHDEN CORP. 90 ICON STREET Foothill Ranch, CA 92610 |
| Product Code | GWF |
| Subsequent Product Code | GWE |
| Subsequent Product Code | GWJ |
| Subsequent Product Code | GWQ |
| Subsequent Product Code | GZO |
| Subsequent Product Code | IKN |
| CFR Regulation Number | 882.1870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-02-08 |
| Decision Date | 2012-09-19 |
| Summary: | summary |