Identifiers
- 510(k) Number
- K030931 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 C3 Patient Monitor is a physiological patient monitoring device designed for continuous monitoring of adult patients. It provides real-time measurements of electrocardiogram (ECG), heart rate, non-invasive blood pressure (NIBP), functional arterial oxygen saturation (SpO₂), respiration rate, temperature, and carbon dioxide (CO₂) levels, with integrated arrhythmia detection and alarm capabilities.
This device is intended for single-patient use in clinical settings and is classified under 21 CFR 870.1025 as an arrhythmia detector and alarm. It is supplied as a reusable medical device and has received FDA 510(k) clearance under the Special review pathway, with a decision code of SESE (Substantially Equivalent, Special). The product code assigned is MHX, and it falls under the Cardiovascular advisory committee classification.
Frequently asked questions
Is the C3 Patient Monitor designed for single-use or reusable applications in clinical settings?
The C3 Patient Monitor is explicitly classified as a reusable medical device. It is intended for continuous monitoring of adult patients in clinical environments, meaning it is not meant for single-use but rather for repeated use across multiple patients after proper cleaning, disinfection, and maintenance.
What types of physiological measurements does the C3 Patient Monitor provide, and how does it alert clinicians?
The C3 Patient Monitor provides real-time measurements of electrocardiogram (ECG), heart rate, non-invasive blood pressure (NIBP), arterial oxygen saturation (SpO₂), respiration rate, temperature, and carbon dioxide (CO₂) levels. It includes integrated arrhythmia detection and alarm capabilities to notify clinicians of abnormal heart rhythms or critical changes in patient status.
How is the C3 Patient Monitor regulated, and what does its FDA clearance status indicate?
The C3 Patient Monitor received FDA 510(k) clearance under the Special review pathway, with a decision code of SESE (Substantially Equivalent, Special). This indicates that the device was determined to be substantially equivalent to a legally marketed predicate device, meeting FDA requirements for safety and effectiveness. The clearance falls under the Cardiovascular advisory committee classification.
What clinical setting or patient population is the C3 Patient Monitor intended for?
The C3 Patient Monitor is designed for continuous monitoring of adult patients in clinical settings. While the device measures a broad range of physiological parameters, its regulatory classification under 21 CFR 870.1025 as an *arrhythmia detector and alarm* suggests its primary focus is on cardiac monitoring and alerting clinicians to abnormal heart rhythms.
Are there multiple models or configurations of the C3 Patient Monitor, or is it a single unified device?
The provided data lists multiple FEI numbers (e.g., 3021219789, 1051088) under the C3 Patient Monitor, which typically correspond to different models, variants, or configurations of the device. While the core functionality remains consistent, these identifiers suggest there may be variations in specifications or features across different versions, though the exact differences are not detailed in the data.
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. Sources consulted: C3 PATIENT MONITOR by ANALOGIC CORP. | FDA 510 (k) Summary, C3 PATIENT MONITOR (K030931) — FDA 510 (k) | Innolitics, C3 PATIENT MONITOR 510 (k) K030931 - FDA.report
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K030931 | Class II | Active |
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Manufacturer
- Manufacturer
- Analogic Corp.
Sources (1)
- FDA 510(k) K030931 24 fields · synced Sep 19, 2026