Identifiers
- 510(k) Number
- K082465 FDA 510(k)
- FDA Product Code
- BZQ FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 868.2375 FDA 510(k)
- Regulation Number
- 868.2375 FDA 510(k)
- Advisory Committee
- Anesthesiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The EverOn system is a contact-free patient monitoring device that measures and records respiration rate and heart rate automatically. It is designed for use in home, hospital, or clinic settings and can be used with children and adolescents. The system operates without direct contact with the patient, providing continuous monitoring from under the mattress.
The EverOn system is supplied as a monitoring device with FDA 510(k) clearance (K082465) under product code BZQ. It is a Class II medical device intended for continuous measurement of vital signs. The device is not specified as single-use or reusable, and no information regarding MRI safety or sterility is provided in the data.
Frequently asked questions
What is the EverOn system used for?
The EverOn system is a contact-free patient monitoring device designed to automatically measure and record respiration rate and heart rate. It provides continuous monitoring for children and adolescents in home, hospital, or clinic settings without direct contact with the patient.
How is the EverOn system supplied?
The EverOn system is supplied as a monitoring device with FDA 510(k) clearance under product code BZQ. It is a Class II medical device intended for continuous measurement of vital signs, though the data does not specify whether it is single-use or reusable.
What are the regulatory approvals for the EverOn system?
The EverOn system has FDA 510(k) clearance with number K082465, classified as a Class II medical device under product code BZQ. It was determined to be substantially equivalent to other devices in this category through the traditional clearance process.
Where can the EverOn system be used?
The EverOn system is designed for use in various settings including home environments, hospitals, and clinics. It can be used with both children and adolescents, providing continuous monitoring from under the mattress without requiring direct contact with the patient.
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: EarlySense - Crunchbase Company Profile & Funding, EVERON by EARLYSENSE LTD. | FDA 510 (k) Summary, EVERON (K082465) — 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 | K082465 | Class II | Active |
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Manufacturer
- Manufacturer
- Earlysense, Ltd.
Sources (1)
- FDA 510(k) K082465 24 fields · synced Sep 23, 2026