The following data is part of a premarket notification filed by Spacelabs Healthcare with the FDA for Elance Vital Signs Monitor, Central Monitor Software.
| Device ID | K150329 |
| 510k Number | K150329 |
| Device Name: | Elance Vital Signs Monitor, Central Monitor Software |
| Classification | Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) |
| Applicant | SPACELABS HEALTHCARE 35301 SE CENTER STREET Snoqualmie, WA 98065 |
| Contact | Al Van Houdt |
| Correspondent | Thomas Kroenke Speed To Market, Inc. PO 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 | 2015-02-10 |
| Decision Date | 2015-11-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10841522128479 | K150329 | 000 |
| 10841522128462 | K150329 | 000 |
| 10841522128455 | K150329 | 000 |