Clearance Summary
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 received FDA 510(k) clearance under submission number K213316, sponsored by Nihon Kohden Corporation. The device was reviewed via the Special premarket notification pathway and assigned to the Anesthesiology review panel. The statutory decision date of record is 2021-12-29.
- Submission: K213316
- Applicant / Sponsor: Nihon Kohden Corporation
- Clearance pathway: Special
- Review panel: Anesthesiology
- Device class: Class II
- Regulation citation: 21 CFR 868.2775
- Decision date: 2021-12-29
Classification & Regulation
This clearance is catalogued under FDA product code KOI and 21 CFR 868.2775, within the Anesthesiology review panel as a Class II device.