The following data is part of a premarket notification filed by Philips Medizinsysteme Boblingen Gmbh with the FDA for Modification To Agilent Component Monitoring System (cms), V24/v26 Patient Monitors, Blood Analysis Portal System Plug-i.
| Device ID | K013624 |
| 510k Number | K013624 |
| Device Name: | MODIFICATION TO AGILENT COMPONENT MONITORING SYSTEM (CMS), V24/V26 PATIENT MONITORS, BLOOD ANALYSIS PORTAL SYSTEM PLUG-I |
| Classification | Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) |
| Applicant | PHILIPS MEDIZINSYSTEME BOBLINGEN GMBH 3000 MINUTEMAN RD. Andover, MA 01810 |
| Contact | Denise Haley |
| Correspondent | Denise Haley PHILIPS MEDIZINSYSTEME BOBLINGEN GMBH 3000 MINUTEMAN RD. Andover, MA 01810 |
| Product Code | MHX |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-11-05 |
| Decision Date | 2001-12-03 |
| Summary: | summary |