510(k) K242750

Central Station by Nihon Kohden Digital Health Solutions, LLC — Product Code MSX

K242750 is an FDA 510(k) premarket notification submitted by Nihon Kohden Digital Health Solutions, LLC for the device "Central Station". The FDA issued a decision of Substantially Equivalent on June 5, 2025. 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 Digital Health Solutions, LLC has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 5, 2025
Date Received
September 12, 2024
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