Tempus Pro Patient Monitor
FDA 510(k) K170567 · Remote Diagnostic Technologies , Ltd.
510(k) numberK170567
Submission
- Device name
- Tempus Pro Patient Monitor
- Applicant
- Remote Diagnostic Technologies , Ltd.
Basingstoke, GB - Received
- February 27, 2017
- Decision date
- July 6, 2017
- 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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| K260579 | Infinity® Acute Care System (IACS) VG8.1MHX · Traditional | Draeger Medical Systems, Inc. | 08/20/2026SE |
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| 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 |
|---|---|---|
| K201746 | Tempus Pro Patient MonitorMHX · Special | 09/18/2020SE |
| K173768 | Tempus Pro Patient MonitorMHX · Special | 01/10/2018SE |
| K133973 | Tempus Pro with Enhanced FeaturesQYW · Abbreviated | 08/14/2014SE |
| K134014 | Tempus Pro Accessories (Ultrasound & Video Laryngoscope Probe)MWI · Traditional | 08/12/2014SE |
| K133988 | Tempus Pro Extended FeaturesMWI · Abbreviated | 05/16/2014SE |
| K130773 | Tempus Pro Patient MonitorMWI · Traditional | 06/05/2013SE |
| K113105 | Tempusic Patient MonitorMWI · Abbreviated | 12/15/2011SE |
| K101264 | Tempus Ic Professional Patient MonitorMWI · Traditional | 05/11/2010SE |
| K082718 | Tempusic Patient MonitorDXH · Traditional | 10/10/2008SE |
| K033410 | Tempus 2000 Patient Monitor, Model 00-0002DXH · Traditional | 03/05/2004SE |
Questions and answers
When was Tempus Pro Patient Monitor cleared by the FDA?
Tempus Pro Patient Monitor (K170567) received a 510(k) decision of Substantially Equivalent on July 6, 2017, 129 days after the submission was received.
What is the product code of K170567?
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.