Critical Alert CommonPath Enterprise
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K193043 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)
The Critical Alert CommonPath Enterprise is a physiological monitoring system designed for cardiovascular applications. It functions as a network and communication device for monitoring physiological parameters in clinical settings.
This device is supplied by Critical Alert and is authorized under FDA 510K clearance. It is a Class II medical device with product code MSX, intended for use in cardiovascular monitoring environments. The system includes various registration numbers and is regulated under 870.2300.
Frequently asked questions
What is the Critical Alert CommonPath Enterprise used for?
The Critical Alert CommonPath Enterprise is a physiological monitoring system designed specifically for cardiovascular applications. It functions as a network and communication device for monitoring physiological parameters in clinical settings, providing essential data for patient care.
How is the CommonPath Enterprise supplied and what is its regulatory status?
The device is supplied by Critical Alert and is authorized under FDA 510K clearance. It is classified as a Class II medical device with product code MSX, regulated under 870.2300, and intended for use in cardiovascular monitoring environments.
What are the key specifications of the CommonPath Enterprise system?
The Critical Alert CommonPath Enterprise is a physiological monitoring system that functions as a network and communication device. It is a Class II medical device with product code MSX, designed for cardiovascular monitoring in clinical settings, and has received FDA 510K clearance with decision code SESE.
Who manufactures the CommonPath Enterprise and where is it located?
The CommonPath Enterprise is manufactured by Critical Alert, located at 4901 Belfort Rd., Suite 130, Jacksonville, FL 32256. The company contact is John Elms, and the device received FDA clearance on May 11, 2020.
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 (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K193043 | Class II | Active |
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Manufacturer
- Manufacturer
- Critical Alert
Sources (1)
- FDA 510(k) K193043 24 fields · synced Sep 21, 2026