Identifiers
- 510(k) Number
- K113054 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)
Equivital is a physiological patient monitor with arrhythmia detection or alarms, classified as a Class II medical device. It is substantially equivalent to a predicate device and received special 510(k) clearance from the FDA.
The device is manufactured by Hidalgo Limited and is authorized for distribution in the United Kingdom. It is intended for use in cardiovascular monitoring applications as indicated by the advisory committee classification.
Frequently asked questions
What is the Equivital device intended for?
The Equivital device is intended for cardiovascular monitoring applications, as indicated by the advisory committee classification. It functions as a physiological patient monitor with arrhythmia detection or alarms, designed to support clinical monitoring of heart activity in patients.
How was the Equivital device cleared for marketing in the United States?
The Equivital device received special 510(k) clearance from the FDA, meaning it was found to be substantially equivalent to a legally marketed predicate device. This clearance pathway is used for Class II medical devices that demonstrate similar safety and effectiveness to an existing device.
What regulatory classification does the Equivital device have?
The Equivital device is classified as a Class II medical device by the FDA, based on its product code MHX and regulation number 870.1025. This classification reflects its risk level and the regulatory controls required to ensure its safety and effectiveness.
Who manufactures the Equivital device and where is it authorized for distribution?
The Equivital device is manufactured by Hidalgo Limited and is authorized for distribution in the United Kingdom. The manufacturer’s address is listed as Unit F Buckinghamway Business Park, Anderson Rd., Swavesey, Cambridge, CB24 4UQ, United Kingdom.
What does the term 'substantially equivalent' mean in relation to the Equivital device?
The term 'substantially equivalent' means that the Equivital device has the same intended use and similar technological characteristics as a predicate device already legally marketed in the U.S., and it does not raise new questions of safety or effectiveness. This determination was made by the FDA during its special 510(k) review process.
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: Equivital Company Profile - Office Locations, Competitors, Revenue ..., HIDALGO LIMITED Company Profile | CAMBRIDGE | Competitors, Financials ..., EQUIVITAL LIMITED overview - Find and update company information - GOV.UK, Hidalgo Limited - Company Profile - Endole
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K113054 | Class II | Active |
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Manufacturer
- Manufacturer
- Hidalgo Limited
Sources (1)
- FDA 510(k) K113054 24 fields · synced Oct 6, 2026