510(k) K223567

CNS-2101 Central Monitor by Nihon Kohden Corporation — Product Code MSX

K223567 is an FDA 510(k) premarket notification submitted by Nihon Kohden Corporation for the device "CNS-2101 Central Monitor". The FDA issued a decision of Substantially Equivalent on July 31, 2023. The device falls under product code MSX (System, Network And Communication, Physiological Monitors), a Class II device regulated under 21 CFR 870.2300. Nihon Kohden Corporation has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 31, 2023
Date Received
November 29, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Network And Communication, Physiological Monitors
Device Class
Class II
Regulation Number
870.2300
Review Panel
CV
Submission Type