Submission Details
| 510(k) Number | K213316 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | October 04, 2021 |
| Decision Date | December 29, 2021 |
| Days to Decision | 86 days |
| Submission Type | Special |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
Cleared
Special
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
Dec 2021
Decision
86d
Days
Class 2
Risk
About This 510(k) Submission
K213316 is an FDA 510(k) clearance for the 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, a Stimulator, Nerve, Peripheral, Electric (Class II — Special Controls, product code KOI), submitted by Nihon Kohden Corporation (Tokyo, JP). The FDA issued a Cleared decision on December 29, 2021, 86 days after receiving the submission on October 4, 2021. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.2775.
Device Classification
| Product Code | KOI — Stimulator, Nerve, Peripheral, Electric |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 868.2775 |
Manufacturer
Similar Devices — KOI Stimulator, Nerve, Peripheral, Electric
All 27
K250887 · MIPM Mammendorfer Institut f?r Physik und Medizin GmbH
· Oct 2025
K243339 · Idmed
· Jun 2025
K242525 · Nerbio Medical Software Platforms, Inc.
· Dec 2024
K220530 · Senzime AB
· Aug 2022
K220976 · Nihon Kohden Corporation
· Jul 2022
K212434 · MIPM Mammendorfer Institut f?r Physik und Medizin GmbH
· May 2022
More from Nihon Kohden Corporation
View all
K251366
· OLT · Oct 2025
K243956
· CCK · Jun 2025
K223567
· MSX · Jul 2023
K220976
· KOI · Jul 2022
K203435
· MHX · Jul 2021