The following data is part of a premarket notification filed by Philips Medical Systems North America Co. with the FDA for Suresigns Vs2 Vital Signs Monitor, Suresigns Vm1 Patient Monitor, Suresigns Vs3 Cital Signs Monitor.
| Device ID | K082280 |
| 510k Number | K082280 |
| Device Name: | SURESIGNS VS2 VITAL SIGNS MONITOR, SURESIGNS VM1 PATIENT MONITOR, SURESIGNS VS3 CITAL SIGNS MONITOR |
| Classification | Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) |
| Applicant | PHILIPS MEDICAL SYSTEMS NORTH AMERICA CO. 22100 BOTHELL EVERETT HIGHWAY Bothell, WA 98021 -8431 |
| Contact | Mary Kruitwagen |
| Correspondent | Mary Kruitwagen PHILIPS MEDICAL SYSTEMS NORTH AMERICA CO. 22100 BOTHELL EVERETT HIGHWAY Bothell, WA 98021 -8431 |
| Product Code | MHX |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-08-11 |
| Decision Date | 2008-10-08 |
| Summary: | summary |