The following data is part of a premarket notification filed by Philips Medical Systems with the FDA for Suresigns Vm Series Patient Monitor, Models Vm4, Vm6, Vm8, Vm3 And Vs3.
| Device ID | K080495 |
| 510k Number | K080495 |
| Device Name: | SURESIGNS VM SERIES PATIENT MONITOR, MODELS VM4, VM6, VM8, VM3 AND VS3 |
| Classification | Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) |
| Applicant | PHILIPS MEDICAL SYSTEMS 3000 MINUTEMAN RD. Andover, MA 01810 -1099 |
| Contact | Mary Kruitwagen |
| Correspondent | Mary Kruitwagen PHILIPS MEDICAL SYSTEMS 3000 MINUTEMAN RD. 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 | 2008-02-22 |
| Decision Date | 2008-03-24 |
| Summary: | summary |