Central Monitoring System
FDA 510(k) K170514 · Guangdong Biolight Meditech Co., Ltd.
510(k) numberK170514
Submission
- Device name
- Central Monitoring System
- Applicant
- Guangdong Biolight Meditech Co., Ltd.
Zhuhai, CN - Received
- February 21, 2017
- Decision date
- May 24, 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 |
| 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 |
|---|---|---|
| K181919 | Patient MonitorMWI · Traditional | 04/05/2019SE |
| K162234 | Truscope Ultra Patient MonitorMWI · Special | 01/04/2017SE |
| K160349 | Electronic SphygmomanometerDXN · Traditional | 11/03/2016SE |
| K153580 | Central Monitoring SystemHGM · Traditional | 09/07/2016SE |
| K153135 | Vital Signs MonitorMWI · Special | 02/25/2016SE |
| K152739 | Electronic ThermometerFLL · Traditional | 02/09/2016SE |
| K151287 | Fingertip Pulse Oximeters M70, M70A, M70B, M70C, M70DDQA · Traditional | 01/06/2016SE |
| K131858 | Digital ElectrocardiographDPS · Traditional | 06/11/2014SE |
| K131762 | Handheld MonitorMWI · Traditional | 06/06/2014SE |
| K131941 | Fetal MonitorsHGM · Traditional | 05/15/2014SE |
Questions and answers
When was Central Monitoring System cleared by the FDA?
Central Monitoring System (K170514) received a 510(k) decision of Substantially Equivalent on May 24, 2017, 92 days after the submission was received.
What is the product code of K170514?
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.