The following data is part of a premarket notification filed by Nakanishi Inc. with the FDA for Nlz Motor System.
| Device ID | K163402 |
| 510k Number | K163402 |
| Device Name: | NLZ Motor System |
| Classification | Controller, Foot, Handpiece And Cord |
| Applicant | NAKANISHI INC. 700 Shimohinata Kanuma-shi, JP 322-8666 |
| Contact | Kimihiko Satoh |
| Correspondent | Izumi Maruo MIC International Corp. 4-1-17 Hongo Bunkyo-ku, JP 1130033 |
| Product Code | EBW |
| CFR Regulation Number | 872.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-12-05 |
| Decision Date | 2017-08-31 |