The following data is part of a premarket notification filed by Nihon Kohden America, Inc. with the FDA for Nihon Kohden Meb-2200a Neuropack Evoked Potential & Emg Measuring System With Accessories.
| Device ID | K991899 |
| 510k Number | K991899 |
| Device Name: | NIHON KOHDEN MEB-2200A NEUROPACK EVOKED POTENTIAL & EMG MEASURING SYSTEM WITH ACCESSORIES |
| Classification | Stimulator, Electrical, Evoked Response |
| Applicant | NIHON KOHDEN AMERICA, INC. 2601 CAMPUS DR. Irvine, CA 92612 -1601 |
| Contact | Bonnie Bishop |
| Correspondent | Bonnie Bishop NIHON KOHDEN AMERICA, INC. 2601 CAMPUS DR. Irvine, CA 92612 -1601 |
| Product Code | GWF |
| 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 | 1999-06-04 |
| Decision Date | 1999-09-01 |
| Summary: | summary |