The following data is part of a premarket notification filed by Nihon Kohden Corporation with the FDA for Neuromaster G1 Mee200.
| Device ID | K142624 |
| 510k Number | K142624 |
| Device Name: | Neuromaster G1 MEE200 |
| Classification | Stimulator, Electrical, Evoked Response |
| Applicant | Nihon Kohden Corporation 1-31-4 Nisahiochiai, Shinjuku-Ku Tokyo, JP 161-8560 |
| Contact | Natalie Kennel |
| Correspondent | Natalie J. Kennel NJK & Associates 13721 Via Tres Vista San Diego, CA 92129 |
| Product Code | GWF |
| CFR Regulation Number | 882.1870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-09-16 |
| Decision Date | 2015-04-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04931921900970 | K142624 | 000 |
| 00841983103612 | K142624 | 000 |
| 00841983103018 | K142624 | 000 |
| 00841983100819 | K142624 | 000 |
| 00841983100802 | K142624 | 000 |
| 00841983100796 | K142624 | 000 |
| 00841983100789 | K142624 | 000 |
| 00841983100772 | K142624 | 000 |
| 00841983100598 | K142624 | 000 |
| 00841983100581 | K142624 | 000 |
| 00841983103629 | K142624 | 000 |
| 04931921118054 | K142624 | 000 |
| 04931921130698 | K142624 | 000 |
| 04931921130216 | K142624 | 000 |
| 04931921118139 | K142624 | 000 |
| 04931921118115 | K142624 | 000 |
| 04931921118108 | K142624 | 000 |
| 04931921118092 | K142624 | 000 |
| 04931921118085 | K142624 | 000 |
| 04931921118078 | K142624 | 000 |
| 04931921118061 | K142624 | 000 |
| 00841983100215 | K142624 | 000 |