The following data is part of a premarket notification filed by Nihon Kohden Corporation with the FDA for Life Scope Pt Bsm-1700 Series, Ay Series, Data Acquisition Unit, Life Scope Bsm 6000 Series Bedside Monitoring System, Nihon Kohden Csm-1901 Bedside Monitoring System.
| Device ID | K213316 |
| 510k Number | K213316 |
| Device Name: | Life Scope PT BSM-1700 Series, AY Series, Data Acquisition Unit, LIFE SCOPE BSM 6000 SERIES BEDSIDE MONITORING SYSTEM, Nihon Kohden CSM-1901 BEDSIDE MONITORING SYSTEM |
| 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-10-04 |
| Decision Date | 2021-12-29 |