Intellivue Patient Monitor
FDA 510(k) K113657 · Philips Medizin Systeme Boblingen GmbH
510(k) numberK113657
Submission
- Device name
- Intellivue Patient Monitor
- Applicant
- Philips Medizin Systeme Boblingen GmbH
Boeblingen, DE - Received
- December 12, 2011
- Decision date
- March 22, 2012
- 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
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 |
|---|---|---|
| K151736 | Philips IntelliVue GuardianSoftwareDXJ · Special | 10/21/2015SE |
| K140535 | Philips Avalon Fetal / Maternal Monitors FM20, FM30, FM40 and FM50HGM · Abbreviated | 11/25/2014SE |
| K102958 | Philips Avalon Fetal MonitorHGM · Traditional | 03/18/2011SE |
| K102562 | Intellivue Patient Monitor, Models MP2, X2, MP5, MP5T, MP20, MP30, MP40, MP50, MP60…MHX · Special | 10/21/2010SE |
| K090360 | Philips M3001A Multi Measurement ServerDQA · Special | 05/04/2009SE |
| K083228 | Philips Intellivue MP5 Patient MonitorMHX · Special | 11/24/2008SE |
| K060541 | The Philips MP20,MP30,MP40,MP50,MP60,MP70,MP80 and MP90 Intellivue Atient MonitorsMHX · Special | 03/24/2006SE |
| K042845 | The Philips MP20, MP30, MP40, MP50, MP60, MP70, and MP90 Intellivue Patient MonitorsMSX · Special | 11/12/2004SE |
| K032858 | The Philips Intellivue MP40, MP50, MP60, MP70,AND MP90 Patient Monitors, Release B.O.DSI · Special | 10/10/2003SE |
| K031481 | The Philips Intellivue MP60, MP70, and MP90 Patient Monitors, Release A.20MHX · Special | 05/29/2003SE |
Questions and answers
When was Intellivue Patient Monitor cleared by the FDA?
Intellivue Patient Monitor (K113657) received a 510(k) decision of Substantially Equivalent on March 22, 2012, 101 days after the submission was received.
What is the product code of K113657?
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.