510(k) K242750
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