510(k) K013624
MODIFICATION TO AGILENT COMPONENT MONITORING SYSTEM (CMS), V24/V26 PATIENT MONITORS, BLOOD ANALYSIS PORTAL SYSTEM PLUG-I by
Philips Medizin Systeme Boblingen GmbH
— Product Code MHX
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 3, 2001
- Date Received
- November 5, 2001
- Clearance Type
- Special
- 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