Multi-Parameter Patient Monitor C30
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K173454 FDA 510(k)
- FDA Product Code
- MHX FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.1025 FDA 510(k)
- Regulation Number
- 870.1025 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Multi-Parameter Patient Monitor C30 is a physiological patient monitoring device designed for continuous, multi-channel assessment of vital signs. It detects arrhythmias and provides audible or visual alarms to alert clinicians to abnormal cardiac rhythms, supporting real-time patient monitoring in clinical settings.
This device is intended for use in hospital environments, including intensive care units, emergency departments, and operating rooms. Supplied as a reusable medical instrument, it requires adherence to manufacturer cleaning and sterilisation protocols. The monitor is classified as a Class II device under FDA regulations and complies with the Medical Device Directive (MDD) and Medical Device Regulation (MDR) in the EU. It is not MRI-safe and must be stored in a controlled environment to maintain functionality and hygiene.
Frequently asked questions
What clinical environments is this monitor designed for and what makes it suitable for those settings?
The Multi-Parameter Patient Monitor C30 is specifically designed for high-acuity clinical environments such as intensive care units, emergency departments, and operating rooms. Its suitability stems from its ability to continuously monitor multiple vital signs and detect arrhythmias, providing audible or visual alarms to alert clinicians to abnormal cardiac rhythms in real-time. This ensures timely intervention, which is critical in fast-paced and high-stakes settings like these.
Is this device single-use or reusable, and what cleaning and sterilization protocols must be followed?
The Multi-Parameter Patient Monitor C30 is a reusable medical instrument. To maintain functionality and hygiene, it must be cleaned and sterilized according to the manufacturer’s specified protocols. Proper adherence to these protocols is essential to ensure the device remains safe for repeated use in clinical settings.
Can this monitor be used in an MRI environment, and if not, what storage conditions are required?
No, the Multi-Parameter Patient Monitor C30 is explicitly not MRI-safe. To preserve its functionality and hygiene, it must be stored in a controlled environment, as outlined by the manufacturer’s guidelines. This ensures optimal performance and reduces the risk of contamination or damage.
What regulatory pathways has this device undergone, and which regions does it comply with?
The Multi-Parameter Patient Monitor C30 has undergone FDA clearance via a 510(k) submission, classified as a Class II device under FDA regulations. It also complies with the Medical Device Directive (MDD) and Medical Device Regulation (MDR) in the European Union, ensuring its suitability for use in both U.S. and EU healthcare settings.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Active |
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K173454 | Class II | Active |
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Manufacturer
- Manufacturer
- Shenzhen Comen Medical Instruments Co., LTD.
- FDA Applicant
- Shenzhen Comen Medical Instruments Co.,Ltd
Sources (2)
- FDA 510(k) K173454 24 fields · synced Oct 6, 2026
- EUDAMED 1 fields · synced May 18, 2026