The following data is part of a premarket notification filed by Philips Medical Systems with the FDA for Sursigns Vs2 Vital Signs Monitor, Suresigns Vs3 Vital Signs Monitor, Suresigns Vm Series Patient Monitors.
| Device ID | K090483 |
| 510k Number | K090483 |
| Device Name: | SURSIGNS VS2 VITAL SIGNS MONITOR, SURESIGNS VS3 VITAL SIGNS MONITOR, SURESIGNS VM SERIES PATIENT MONITORS |
| Classification | Electrocardiograph |
| Applicant | PHILIPS MEDICAL SYSTEMS 3000 MINUTEMAN RD. Andover, MA 01810 -1099 |
| Contact | Larry Milana |
| Correspondent | Larry Milana PHILIPS MEDICAL SYSTEMS 3000 MINUTEMAN RD. Andover, MA 01810 -1099 |
| Product Code | DPS |
| Subsequent Product Code | CCK |
| Subsequent Product Code | DQA |
| Subsequent Product Code | DXN |
| Subsequent Product Code | FFL |
| CFR Regulation Number | 870.2340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-02-25 |
| Decision Date | 2009-03-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884838028906 | K090483 | 000 |
| 00884838009691 | K090483 | 000 |
| 00884838009684 | K090483 | 000 |