510(k) K251702
IntelliVue Patient Monitor MX750; IntelliVue Patient Monitor MX850; IntelliVue 4-Slot Module Rack FMX-4 (866471 866470 866468 ) by
Philips Medizin Systeme Böblingen GmbH
— Product Code MHX
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 10, 2025
- Date Received
- June 2, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
- Device Class
- Class II
- Regulation Number
- 870.1025
- Review Panel
- CV
- Submission Type