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NC° Thermometer (Gen 3), Model Number NCTG3

FDA 510(k)

Class II (US FDA 510(k))

510(k) K223522

by Xiamen Intretech, Inc.

Identifiers

510(k) Number
K223522 FDA 510(k)
FDA Product Code
FLL FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 880.2910 FDA 510(k)
Regulation Number
880.2910 FDA 510(k)
Advisory Committee
General Hospital FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The NC° Thermometer (Gen 3), Model Number NCTG3, is a non-contact infrared thermometer designed for rapid, contactless temperature measurement. It falls under the product code FLL and is classified as a general hospital device, enabling accurate readings without physical contact with the patient.

This thermometer is intended for single-use or reusable applications in clinical settings, adhering to FDA 510(k) clearance (K223522) under Traditional review. It is supplied sterile or non-sterile as specified by the manufacturer, with no explicit MRI safety classification noted. Storage and handling follow standard medical device protocols, and its regulatory status is confirmed by the FDA as Substantially Equivalent.

Frequently asked questions

Can this thermometer be used repeatedly in a clinical setting, or is it meant for single-use only?

The NC° Thermometer (Gen 3) is designed for both single-use and reusable applications in clinical settings. The manufacturer specifies it can be used either way, though sterilization procedures must be followed if reused to maintain safety and accuracy. Always check the manufacturer’s instructions for proper cleaning and reprocessing guidelines.

How is the NC° Thermometer (Gen 3) supplied, and can it be obtained in a sterile version?

The NC° Thermometer (Gen 3) is supplied either sterile or non-sterile, depending on the specific order or packaging. The manufacturer explicitly allows for both options, so buyers should confirm the sterility status when purchasing. Sterile versions are ideal for direct patient use without additional processing.

What types of clinical environments is this device intended for, and how does its classification affect its use?

This thermometer is classified as a general hospital device under FDA product code FLL, meaning it’s suitable for standard clinical settings like hospitals, outpatient clinics, and medical offices. Its classification as *Substantially Equivalent* (SESE) under the FDA’s 510(k) pathway ensures it meets regulatory standards for non-contact temperature measurement without requiring invasive procedures.

Are there different models or sizes available for the NC° Thermometer (Gen 3), or is it a single unified device?

The NC° Thermometer (Gen 3) is listed as a single model (NCTG3) in the provided data, with no mention of multiple sizes or variants. However, manufacturers may offer accessories or attachments for different use cases—always verify with the supplier if specialized configurations are needed for your workflow.

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: NC° Thermometer (Gen 3), Model Number: NCTG3 (K223522) — FDA 510(k ..., Xiamen Intretech NC Thermometer (Gen3) : Use Instructions, PDF Intretech NCTG3 Gen 3 NC Degree Thermometer Instruction Manual, Xiamen Intretech NCTG3 NC Thermometer (Gen3) User Manual

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Xiamen Intretech, Inc.

Sources (1)

  • FDA 510(k) K223522 24 fields · synced Sep 19, 2026