The following data is part of a premarket notification filed by Spacelabs Healthcare Medical Equipment (suzhou) Co with the FDA for Spacelabs Elance Vital Signs Monitoring System And Central Monitor Software.
| Device ID | K090556 |
| 510k Number | K090556 |
| Device Name: | SPACELABS ELANCE VITAL SIGNS MONITORING SYSTEM AND CENTRAL MONITOR SOFTWARE |
| Classification | Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) |
| Applicant | SPACELABS HEALTHCARE MEDICAL EQUIPMENT (SUZHOU) CO P.O. BOX 3018 Nederland, CO 80466 |
| Contact | Thomas Kroenke |
| Correspondent | Thomas Kroenke SPACELABS HEALTHCARE MEDICAL EQUIPMENT (SUZHOU) CO P.O. BOX 3018 Nederland, CO 80466 |
| Product Code | MHX |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-03-02 |
| Decision Date | 2009-04-30 |
| Summary: | summary |