MX40 Release C.01
FDA 510(k) K180017 · Philips Medical Systems
510(k) numberK180017
Submission
- Device name
- MX40 Release C.01
- Applicant
- Philips Medical Systems
Andover, MA, US - Received
- January 2, 2018
- Decision date
- July 24, 2018
- 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
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
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| K211597 | EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound SystemIYN · Traditional | 09/08/2021SE |
| K210560 | Page Writer TC20 Cardiograph, Page Writer TC30 Cardiograph, Page Writer TC50…DPS · Special | 06/30/2021SE |
| K191738 | PageWriter TC20 Cardiograph, PageWriter TC30 Cardiograph, PageWriter TC50 Cardiograph…DPS · Traditional | 09/29/2020SE |
| K192875 | Philips Biosensor BX100DRG · Traditional | 04/16/2020SE |
| K183387 | M3290B Patient Information Center iXMHX · Traditional | 08/06/2019SE |
| K172226 | MX40 Release B.07MHX · Traditional | 11/09/2017SE |
| K163584 | M3290B Philips IntelliVue Information Center iXMHX · Traditional | 07/07/2017SE |
| K163649 | SureSigns VS3; SureSigns VS4DSJ · Special | 03/31/2017SE |
| K161164 | CareEvent inclusive of the CareEvent Mobile Application accessoryMSX · Traditional | 06/24/2016SE |
Questions and answers
When was MX40 Release C.01 cleared by the FDA?
MX40 Release C.01 (K180017) received a 510(k) decision of Substantially Equivalent on July 24, 2018, 203 days after the submission was received.
What is the product code of K180017?
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.