Identifiers
- 510(k) Number
- K010453 FDA 510(k)
- FDA Product Code
- MWI FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.2300 FDA 510(k)
- Regulation Number
- 870.2300 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The M2376A Devicelink System is a cardiac monitor (including cardiotachometer and rate alarm) designed to measure heart rate from analog signals generated by electrocardiographs, vectorcardiographs, or blood pressure monitors. It functions by processing these signals to provide real-time heart rate data and can emit audible or visual alarms when the heart rate exceeds predefined upper or lower limits. This aids in continuous cardiac monitoring, particularly in clinical or critical care settings where rapid assessment of heart rate is essential.
The system is supplied as a reusable medical device and is intended for use in environments where cardiac monitoring is required, such as hospitals, intensive care units, or emergency departments. It is not classified as single-use and must be maintained according to manufacturer guidelines to ensure accurate performance and safety. The device holds FDA 510(k) clearance under classification MWI (Cardiac Monitors) and is regulated under the § 870.2300 category for cardiac monitors. No additional sterility or MRI safety specifications are noted in the available data.
Frequently asked questions
What is the M2376A Devicelink System used for?
The M2376A Devicelink System is designed to measure heart rate in real-time by processing analog signals from electrocardiographs, vectorcardiographs, or blood pressure monitors. It provides continuous cardiac monitoring and can trigger audible or visual alarms when heart rate exceeds predefined upper or lower thresholds, making it ideal for clinical or critical care settings like hospitals, ICUs, or emergency departments.
Is the M2376A Devicelink System reusable or single-use?
The M2376A Devicelink System is a reusable medical device. It is not intended for single-use and must be maintained according to the manufacturer’s guidelines to ensure accurate performance, safety, and reliability over repeated use.
What types of signals can the M2376A Devicelink System process?
The system is specifically designed to process analog signals generated by electrocardiographs, vectorcardiographs, or blood pressure monitors. These signals are converted into real-time heart rate data, enabling continuous cardiac monitoring.
Does the M2376A Devicelink System require any special storage conditions?
The device data does not specify special storage conditions beyond standard manufacturer guidelines for reusable medical devices. It is recommended to follow Agilent Technologies’ maintenance protocols to preserve functionality and ensure safety.
What regulatory approval does the M2376A Devicelink System hold?
The M2376A Devicelink System holds FDA 510(k) clearance under classification MWI (Cardiac Monitors) and is regulated under the § 870.2300 category. The clearance was granted as substantially equivalent through a special review process by the Cardiovascular Advisory Committee in 2001.
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: M2376A DEVICELINK SYSTEM, MODEL M2376A (K003622) — FDA 510 (k) | Innolitics, M2376A DEVICELINK SYSTEM, MODEL M2376A by AGILENT TECHNOLOGIES, INC ..., M2376A DEVICELINK SYSTEM, MODEL M2376A (K002967) — FDA 510 (k) | Innolitics, M2376A DEVICELINK SYSTEM, MODEL M2376A (K003622) — FDA 510 (k) | Innolitics
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K010453 | Class II | Active |
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Manufacturer
- Manufacturer
- Agilent Technologies, Inc.
Sources (1)
- FDA 510(k) K010453 24 fields · synced Oct 1, 2026