Elance Vital Signs Monitor and Elance Central Station
FDA 510(k) K093501 · Spacelabs Medical, Inc.
510(k) numberK093501
Submission
- Device name
- Elance Vital Signs Monitor and Elance Central Station
- Applicant
- Spacelabs Medical, Inc.
Issaquah, WA, US - Received
- November 12, 2009
- Decision date
- November 24, 2009
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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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| K260579 | Infinity® Acute Care System (IACS) VG8.1MHX · Traditional | Draeger Medical Systems, Inc. | 08/20/2026SE |
| K251508 | Telemetry Monitor (iT30, iT50)MHX · Traditional | Edan Instruments, Inc. | 08/06/2026SE |
| K253277 | Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125PMHX · Traditional | Ge Medical Systems Information Technologies, Inc. | 07/24/2026SE |
| K254209 | Radius VSM and AccessoriesMHX · Traditional | Masimo Corporation | 06/04/2026SE |
| K252840 | M12 Telemetry SystemMHX · Traditional | Global Instrumentation, LLC | 05/29/2026SE |
| 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 |
More from Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K120616 | Spacelabs Healthcare Qube Compact Monitor (91390MHX · Special | 03/29/2012SE |
| K112962 | Spacelabs Healthcare Xprezzon Beside MONITOR(9913930)MHX · Special | 11/02/2011SE |
| K102422 | Spacelabs Medical Patient MonitorsMHX · Special | 12/07/2010SE |
| K082045 | Modification to Mcare 300 Vital Signs Monitor, Model 91220MHX · Special | 08/01/2008SE |
| K063490 | Spacelabs Medical Full Disclosure System, Model 91810DQK · Traditional | 03/15/2007SE |
| K062095 | Mcare 300 Vital Signs Monitor, Model 91220MHX · Abbreviated | 09/29/2006SE |
| K062278 | Spacelabs Medical Clinical Event Interface, Model 91847MSX · Special | 09/19/2006SE |
| K060900 | Spacelabs Medical Bispectral Index (Bisx) Analysis Module 91482 and Accessories…OLW · Traditional | 06/23/2006SE |
| K053599 | Spacelabs Medical Multigas Analyzer Module 91518 and AccessoriesCBR · Special | 04/19/2006SE |
| K050605 | Spacelabs Medical Multiparameter Module 91496DSI · Special | 05/03/2005SE |
Questions and answers
When was Elance Vital Signs Monitor and Elance Central Station cleared by the FDA?
Elance Vital Signs Monitor and Elance Central Station (K093501) received a 510(k) decision of Substantially Equivalent on November 24, 2009, 12 days after the submission was received.
What is the product code of K093501?
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.