Valeo Vt-601 Series Ir Thermometer
by Valeo Corp.
510(k) K111463
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK111463 | Date17 Feb 2012 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- FLL
- Device Class
- Class II
- Regulation
- 21 CFR Part 880.2910
- Advisory Committee
- General Hospital
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Valeo VT-601 Series Infrared Thermometer is a non-contact infrared device designed for intermittent measurement of human body temperature and environmental or object temperatures. It operates via infrared detection to provide rapid readings without physical contact, making it suitable for clinical and general hospital settings. The device includes multifunction capabilities, such as fever alarm and memory functions, to enhance usability in monitoring applications. Its classification aligns with non-invasive temperature measurement technologies, ensuring compliance with regulatory standards for diagnostic and screening purposes.
This thermometer is supplied as a reusable electronic device with a measuring range of -20°C to 115°C and a response time of 1 second. It features an auto power-off function, low battery indicator, and optional 2-color backlight for improved visibility in various lighting conditions. The device is intended for use in general hospital environments and has received FDA 510(k) clearance under the traditional review pathway, with a clearance date of February 17, 2012. Models include VT-601D, VT-601E, and VT-601F, each adhering to the same specifications and regulatory requirements.
Other devices from Valeo Corp.
Questions
AI-generated answers, 1 Oct 2026
What is the Valeo VT-601 Series Infrared Thermometer used for?
The Valeo VT-601 Series Infrared Thermometer is designed for non-contact measurement of human body temperature and environmental or object temperatures. Its infrared detection technology allows for quick, contactless readings, making it ideal for clinical and general hospital settings where speed and hygiene are important. This includes applications like screening for fever, monitoring patient temperatures, and assessing room or equipment temperatures.
How is the Valeo VT-601 Series supplied, and is it single-use or reusable?
The Valeo VT-601 Series is supplied as a reusable electronic device. Unlike single-use thermometers, this model is built for repeated use in clinical environments, which helps reduce waste and operational costs. Its durable design ensures reliability over multiple measurements, provided it is properly maintained and calibrated.
What temperature range and response time does the VT-601 Series support?
The device measures temperatures within a broad range of -20°C to 115°C, making it versatile for both human body temperature screening and environmental monitoring. Its response time is 1 second, enabling rapid readings—critical in time-sensitive clinical settings where quick assessments are necessary.
Does the Valeo VT-601 Series come in different models, and what distinguishes them?
Yes, the VT-601 Series includes three models: VT-601D, VT-601E, and VT-601F. While all models share the same core specifications—such as temperature range, response time, and multifunction capabilities—they may differ in minor features like backlight options or additional software functionalities. For example, the models might vary in optional backlight colors (e.g., single-color vs. dual-color) or slight firmware enhancements, but their core performance remains consistent.
How should the Valeo VT-601 Series be stored, and what safety features does it include?
The device should be stored in a clean, dry environment away from direct sunlight or extreme temperatures to preserve its functionality. It includes safety features like an auto power-off function to conserve battery life and a low battery indicator to alert users before operation is compromised. Additionally, its non-contact design minimizes cross-contamination risks, aligning with clinical hygiene standards.