elance Vital Signs Monitor, Central Monitor Software
FDA 510(k) K150329 · Spacelabs Healthcare
510(k) numberK150329
Submission
- Device name
- elance Vital Signs Monitor, Central Monitor Software
- Applicant
- Spacelabs Healthcare
Snoqualmie, WA, US - Received
- February 10, 2015
- Decision date
- November 5, 2015
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MHX – Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1025
- Specialty
- Cardiovascular
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| K260098 | ePM Series Patient Monitor (ePM 10/ePM 10A/ePM 10C/Guardian plus/ ePM 12/ePM 12A/ePM 12C…MHX · Traditional | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 05/20/2026SE |
| K250349 | Vista CMSMHX · Traditional | Shanghai Draeger Medical Instrument Co., Ltd. | 04/24/2026SE |
| K253170 | uMEC 60/ uMEC 70/ uMEC 80/uMEC 100/uMEC 120/uMEC 150 Patient MonitorsMHX · Traditional | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 04/16/2026SE |
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Questions and answers
When was elance Vital Signs Monitor, Central Monitor Software cleared by the FDA?
elance Vital Signs Monitor, Central Monitor Software (K150329) received a 510(k) decision of Substantially Equivalent on November 5, 2015, 268 days after the submission was received.
What is the product code of K150329?
The FDA product code is MHX – Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms), a Class II (moderate risk) device regulated under 21 CFR 870.1025.