Intellivue Patient Monitor MX400, Intellivue Patient Monitor MX450, Intellivue Patient Monitor MX500, Intellivue Patient
FDA 510(k) K141015 · Philips Medizinsysteme Boeblingen GmbH, Cardiac AN
510(k) numberK141015
Submission
- Device name
- Intellivue Patient Monitor MX400, Intellivue Patient Monitor MX450, Intellivue Patient Monitor MX500, Intellivue Patient
- Applicant
- Philips Medizinsysteme Boeblingen GmbH, Cardiac AN
Boeblingen, Baden-Wuerttemberg, DE - Received
- April 21, 2014
- Decision date
- May 19, 2014
- 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
Other 510(k)s with product code MHX
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| K260656 | Carescape ONE; Carescape Dock F0; TruSignal ECG MM; TruSignal PRES MM; TruSignal TEMP…MHX · Traditional | GE Healthcare Finland Oy | 09/01/2026SE |
| K260343 | Carescape Canvas 1000; Carescape Canvas Smart DisplayMHX · Traditional | GE Healthcare Finland Oy | 08/28/2026SE |
| 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 |
|---|---|---|
| K132320 | Intellivue CL Respiration PodBZQ · Traditional | 03/26/2014SE |
| K131872 | Intellivue Patient Monitor MX500, Intellivue Patient Monitor MX550MHX · Special | 10/17/2013SE |
| K131829 | Intellivue Patient MonitorMHX · Special | 08/16/2013SE |
| K130849 | Intellivue Patient Monitor MX400; Intellivue Patient Monitor MX450MHX · Special | 06/14/2013SE |
| K120366 | Intellivue Patient MonitorMHX · Abbreviated | 07/18/2012SE |
| K113441 | Physiological Monitor, Patient MonitorMHX · Traditional | 03/22/2012SE |
| K111905 | Intellivue Guardian Software Model 866009, Intellivue CL SP02 Pod Model 865215…DXJ · Abbreviated | 10/04/2011SE |
| K110474 | Philips Intellivue TCG10LKD · Abbreviated | 09/30/2011SE |
| K111083 | Philips Avalon Fetal/Maternal Monitors FM20, FM30, FM40 and FM50HGM · Abbreviated | 08/17/2011SE |
| K110622 | Intellivue Patient MonitorMHX · Special | 03/31/2011SE |
Questions and answers
When was Intellivue Patient Monitor MX400, Intellivue Patient Monitor MX450, Intellivue Patient Monitor MX500, Intellivue Patient cleared by the FDA?
Intellivue Patient Monitor MX400, Intellivue Patient Monitor MX450, Intellivue Patient Monitor MX500, Intellivue Patient (K141015) received a 510(k) decision of Substantially Equivalent on May 19, 2014, 28 days after the submission was received.
What is the product code of K141015?
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.