Patient Monitor
FDA 510(k) K101692 · Contec Medical System Co., Ltd.
510(k) numberK101692
Submission
- Device name
- Patient Monitor
- Applicant
- Contec Medical System Co., Ltd.
Zhong Shan, Shanghai, CN - Received
- June 16, 2010
- Decision date
- June 28, 2011
- 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 |
|---|---|---|
| K180837 | CONTEC Oxygen ConcentratorCAW · Traditional | 01/10/2019SE |
| K131900 | Contec ElectrocardiographDPS · Traditional | 03/05/2014SE |
| K101273 | Dynamic ECG System Model TLC5000MLO · Traditional | 09/30/2011SE |
| K110156 | Ambulatory Bllod Pressure Monitor, Electronic Sphygmomanometer,DXN · Traditional | 07/27/2011SE |
| K110774 | Electronic SphygmomanometerDXN · Traditional | 05/13/2011SE |
| K101127 | Patient Monitor, Model PM50MWI · Traditional | 06/11/2010SE |
| K090936 | Single-Channel Handheld Electrocardiograph, Model ECG80ADPS · Traditional | 08/25/2009SE |
| K090671 | Pulse Oximeter, Models CMS50E, CMS50F, CMS60C, CMS60DDQA · Traditional | 06/11/2009SE |
| K082480 | Contec Pocket Fetal DopplerKNG · Traditional | 02/25/2009SE |
| K082641 | Fingertip Pulse Oximeter, Models CMS-50D, CMS-50L, CMS-50DLDQA · Special | 11/10/2008SE |
Questions and answers
When was Patient Monitor cleared by the FDA?
Patient Monitor (K101692) received a 510(k) decision of Substantially Equivalent on June 28, 2011, 377 days after the submission was received.
What is the product code of K101692?
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.