The following data is part of a premarket notification filed by Nihon Kohden Corporation with the FDA for Smart Cable Nmt Module And Accessories, Life Scope Bsm 3000 Series And Life Scope Bsm 6000 Series.
| Device ID | K201949 |
| 510k Number | K201949 |
| Device Name: | Smart Cable NMT Module And Accessories, Life Scope BSM 3000 Series And Life Scope BSM 6000 Series |
| Classification | Stimulator, Nerve, Peripheral, Electric |
| Applicant | Nihon Kohden Corporation 1-31-4 Nishiochiai, Shinjuki-Ku Tokyo, JP 161-8560 |
| Contact | Sandra Gadeyne |
| Correspondent | Sunita Teekasingh Nihon Kohden America, Inc. 15353 Barranca Parkway Irvine, CA 92618 |
| Product Code | KOI |
| CFR Regulation Number | 868.2775 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-07-13 |
| Decision Date | 2021-05-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04931921011072 | K201949 | 000 |
| 04931921011089 | K201949 | 000 |
| 04931921006719 | K201949 | 000 |
| 04931921000045 | K201949 | 000 |