The following data is part of a premarket notification filed by Philips Medical Systesms with the FDA for Suresigns Vm Series Patient Monitors, Suresigns Vm4, Suresigns Vm6, And Suresigns Vm8.
| Device ID | K103652 |
| 510k Number | K103652 |
| Device Name: | SURESIGNS VM SERIES PATIENT MONITORS, SURESIGNS VM4, SURESIGNS VM6, AND SURESIGNS VM8 |
| Classification | Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) |
| Applicant | PHILIPS MEDICAL SYSTESMS 300 MINUTEMAN ROAD Andover, MA 01810 -1099 |
| Contact | Lawrence Milana |
| Correspondent | Lawrence Milana PHILIPS MEDICAL SYSTESMS 300 MINUTEMAN ROAD Andover, MA 01810 -1099 |
| Product Code | MHX |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-12-14 |
| Decision Date | 2011-01-13 |
| Summary: | summary |