Identifiers
- 510(k) Number
- K061993 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 Equivital, Model Eq-01 is a physiological patient monitor with arrhythmia detection or alarms, used in the cardiovascular medical specialty. It is designed to monitor vital signs and detect arrhythmias or alarms in patients. The device is classified as a class 2 device. The Equivital, Model Eq-01 is a type of monitor that provides physiological patient monitoring with arrhythmia detection or alarms.
The Equivital, Model Eq-01 is supplied with a product code of MHX and a regulation number of 870.1025. It has been authorized with an FDA 510(k) clearance, with a decision date of November 3, 2006. The device is manufactured by Hidalgo Limited, with a postal code of CB4-5QG. The Equivital, Model Eq-01 is used in a cardiovascular setting and is designed for monitoring physiological patient parameters.
Frequently asked questions
What is the Equivital Eq-01 used for?
The Equivital Eq-01 is used to monitor physiological patient parameters, including vital signs and arrhythmia detection, in a cardiovascular setting.
Is the Equivital Eq-01 a single-use or reusable device?
The device data does not specify whether the Equivital Eq-01 is single-use or reusable, but it is classified as a class 2 device.
What is the regulatory status of the Equivital Eq-01?
The Equivital Eq-01 has been authorized with an FDA 510(k) clearance, with a decision date of November 3, 2006.
What type of monitor is the Equivital Eq-01?
The Equivital Eq-01 is a type of physiological patient monitor with arrhythmia detection or alarms, used in the cardiovascular medical specialty.
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: Hidalgo EQ001 Equivital Vital Signs Monitor type EQ-01-001 User Manual ..., EQ001 Equivital Vital Signs Monitor type EQ-01-001 User Manual ..., EQUIVITAL, MODEL EQ-01 (K061993) — FDA 510(k) | Innolitics, EQ001 Equivital Vital Signs Monitor type EQ-01-001 User Manual HIDA1224 ..., EQUIVITAL, MODEL EQ-01 510 (k) K061993 - 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 | K061993 | Class II | Active |
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Manufacturer
- Manufacturer
- Hidalgo Limited
Sources (1)
- FDA 510(k) K061993 24 fields · synced Oct 6, 2026