The following data is part of a premarket notification filed by Nihon Kohden America, Inc. with the FDA for Neuropack Micro, Model Med-9100a Series.
| Device ID | K010590 |
| 510k Number | K010590 |
| Device Name: | NEUROPACK MICRO, MODEL MED-9100A SERIES |
| Classification | Electromyograph, Diagnostic |
| Applicant | NIHON KOHDEN AMERICA, INC. 90 ICON ST. Foothill Ranch, CA 92610 -1601 |
| Contact | Bonnie Bishop |
| Correspondent | Bonnie Bishop NIHON KOHDEN AMERICA, INC. 90 ICON ST. Foothill Ranch, CA 92610 -1601 |
| Product Code | IKN |
| Subsequent Product Code | GWE |
| Subsequent Product Code | GWF |
| Subsequent Product Code | GWJ |
| Subsequent Product Code | GWQ |
| Subsequent Product Code | GZO |
| Subsequent Product Code | JXE |
| CFR Regulation Number | 890.1375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-02-27 |
| Decision Date | 2001-06-28 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04931921830468 | K010590 | 000 |
| 04931921005477 | K010590 | 000 |
| 04931921005439 | K010590 | 000 |
| 00841983104268 | K010590 | 000 |
| 00841983104251 | K010590 | 000 |
| 00841983103636 | K010590 | 000 |
| 00841983103582 | K010590 | 000 |
| 00841983103575 | K010590 | 000 |
| 00841983103094 | K010590 | 000 |
| 00841983102615 | K010590 | 000 |
| 00841983102134 | K010590 | 000 |
| 00841983102127 | K010590 | 000 |
| 00841983101335 | K010590 | 000 |
| 00841983101328 | K010590 | 000 |
| 00841983101311 | K010590 | 000 |
| 00841983100918 | K010590 | 000 |
| 00841983100864 | K010590 | 000 |
| 04931921005484 | K010590 | 000 |
| 04931921005491 | K010590 | 000 |
| 04931921005545 | K010590 | 000 |
| 04931921123690 | K010590 | 000 |
| 04931921123683 | K010590 | 000 |
| 04931921123676 | K010590 | 000 |
| 04931921119761 | K010590 | 000 |
| 04931921113219 | K010590 | 000 |
| 04931921112847 | K010590 | 000 |
| 04931921104842 | K010590 | 000 |
| 04931921104835 | K010590 | 000 |
| 04931921104828 | K010590 | 000 |
| 04931921102183 | K010590 | 000 |
| 04931921007327 | K010590 | 000 |
| 04931921006429 | K010590 | 000 |
| 04931921005750 | K010590 | 000 |
| 04931921005743 | K010590 | 000 |
| 04931921005736 | K010590 | 000 |
| 04931921005552 | K010590 | 000 |
| 00841983100239 | K010590 | 000 |