C50 and C80 Multi-parameter Patient Monitor
FDA 510(k) K191106 · Shenzhen Comen Medical Instruments Co.,Ltd
510(k) numberK191106
Submission
- Device name
- C50 and C80 Multi-parameter Patient Monitor
- Applicant
- Shenzhen Comen Medical Instruments Co.,Ltd
Shenzhen, CN - Received
- April 25, 2019
- Decision date
- December 13, 2019
- 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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| 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 |
|---|---|---|
| K250854 | Multi-parameter Patient Monitor (N10); Multi-parameter Patient Monitor (N12)…MHX · Traditional | 12/17/2025SE |
| K250190 | Sequential Compression System (SCD600)JOW · Traditional | 12/08/2025SE |
| K211619 | Multi-Parameter Patient MonitorMHX · Traditional | 12/29/2022SE |
| K173454 | Multi-parameter Patient Monitor, models C30MHX · Traditional | 08/16/2018SE |
Questions and answers
When was C50 and C80 Multi-parameter Patient Monitor cleared by the FDA?
C50 and C80 Multi-parameter Patient Monitor (K191106) received a 510(k) decision of Substantially Equivalent on December 13, 2019, 232 days after the submission was received.
What is the product code of K191106?
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.