Argus System-Continuous Expert Care Network
FDA 510(k)Class II (US FDA 510(k))
by Visicu, Inc.
Identifiers
- 510(k) Number
- K001972 FDA 510(k)
- FDA Product Code
- MSX 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)
A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.
The Argus System-Continuous Expert Care Network is a Class II device cleared via FDA 510(k) submission K001972 under regulation number 870.2300. It is manufactured by Visicu, Inc. and assigned product code MSX.
Frequently asked questions
What is the Argus System-Continuous Expert Care Network used for?
It is a cardiac monitor that measures heart rate from analog signals produced by electrocardiographs, vectorcardiographs, or blood pressure monitors, and sounds an alarm when the heart rate falls outside preset upper and lower limits.
How was the Argus System-Continuous Expert Care Network cleared for market?
It was cleared via FDA 510(k) submission K001972 as a Class II device under regulation number 870.2300, determined to be substantially equivalent to a predicate device.
Who manufactures the Argus System-Continuous Expert Care Network and what is its product code?
It is manufactured by Visicu, Inc. and assigned the product code MSX, as specified in the FDA 510(k) clearance documentation.
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: ARGUS SYSTEM-CONTINUOUS EXPERT CARE NETWORK (K001972) — FDA 510(k ..., ARGUS SYSTEM-CONTINUOUS EXPERT CARE NETWORK by VISICU, INC. | FDA 510 ..., Argus System-continuous Expert Care Network 510 (k) FDA Premarket ..., Argus System-continuous Expert Care Network - Beudamed
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K001972 | Class II | Active |
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Manufacturer
- Manufacturer
- Visicu, Inc.
Sources (1)
- FDA 510(k) K001972 24 fields · synced Sep 24, 2026