The following data is part of a premarket notification filed by Nakanishi, Inc. with the FDA for Elec-mate E.
| Device ID | K011926 |
| 510k Number | K011926 |
| Device Name: | ELEC-MATE E |
| Classification | Controller, Foot, Handpiece And Cord |
| Applicant | NAKANISHI, INC. 340 KAMIHINATA, KANUMA-SHI Tochigi-ken, JP 322 |
| Contact | Hiroji Sekiguchi |
| Correspondent | Hiroji Sekiguchi NAKANISHI, INC. 340 KAMIHINATA, KANUMA-SHI Tochigi-ken, JP 322 |
| Product Code | EBW |
| CFR Regulation Number | 872.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-06-20 |
| Decision Date | 2001-09-11 |