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FDA 510(k)

NC° Thermometer (Gen 3), Model Number: NCTG3

K-Number: K223522 · 2023-06-20

ApplicantXiamen Intretech, Inc.
Decision Date2023-06-20
Product CodeFLL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

NC° Thermometer (Gen 3), Model Number: NCTG3 is a medical device manufactured by Xiamen Intretech, Inc.. It received FDA 510(k) clearance on 2023-06-20 under approval number K223522. The device is classified under product code FLL. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NC° Thermometer (Gen 3), Model Number: NCTG3?

NC° Thermometer (Gen 3), Model Number: NCTG3 is a medical device that received FDA 510(k) clearance on 2023-06-20. It is manufactured by Xiamen Intretech, Inc.. The 510(k) number is K223522.

When was NC° Thermometer (Gen 3), Model Number: NCTG3 approved by the FDA?

NC° Thermometer (Gen 3), Model Number: NCTG3 received FDA 510(k) clearance on 2023-06-20, under approval number K223522.

What company makes NC° Thermometer (Gen 3), Model Number: NCTG3?

NC° Thermometer (Gen 3), Model Number: NCTG3 is manufactured by Xiamen Intretech, Inc..

What is the FDA product code for NC° Thermometer (Gen 3), Model Number: NCTG3?

The FDA product code for NC° Thermometer (Gen 3), Model Number: NCTG3 is FLL.

Related Clinical Trials

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Related PubMed Literature

PMID: 41915420 Analysis Model for Infant Incubator Adverse Events Using Retrieval-Augmented Generation Combined With Dual-Adapter Fine-Tuning: Development and Evaluation Study. JMIR medical informatics (2026)

Related Devices (Code: FLL)

K160306Cloud Smart ThermometerGuangzhou Bosma Technology Co, Ltd. K161728Microlife Digital Infrared Forehead Thermometer, Model FR1MN1-1Microfile Intellectual Property GmbH K161735Non-contact Forehead ThermometerShenzhen Dongdixin Technology Co., Ltd. K160816Infrared Thermometer (Model: LX-26E, LX-260TE, PRO LX-261E, LX-360, LX-361T, BW-CX10)Nexmed Technology Co., Ltd. K161211Digital ThermometerBiocare Asia Corporation , Ltd. K160802Infrared Forehead Thermometer, FT-100AHangzhou Universal Electronic Co., Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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