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FDA 510(k)

Infrared Thermometer, Model Number CK-T1501, CK-T1502, CK-T1503

K-Number: K193253 · 2020-06-17

ApplicantShenzhen Changkun Technology Co., Ltd.
Decision Date2020-06-17
Product CodeFLL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Infrared Thermometer, Model Number CK-T1501, CK-T1502, CK-T1503 is a medical device manufactured by Shenzhen Changkun Technology Co., Ltd.. It received FDA 510(k) clearance on 2020-06-17 under approval number K193253. 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 Infrared Thermometer, Model Number CK-T1501, CK-T1502, CK-T1503?

Infrared Thermometer, Model Number CK-T1501, CK-T1502, CK-T1503 is a medical device that received FDA 510(k) clearance on 2020-06-17. It is manufactured by Shenzhen Changkun Technology Co., Ltd.. The 510(k) number is K193253.

When was Infrared Thermometer, Model Number CK-T1501, CK-T1502, CK-T1503 approved by the FDA?

Infrared Thermometer, Model Number CK-T1501, CK-T1502, CK-T1503 received FDA 510(k) clearance on 2020-06-17, under approval number K193253.

What company makes Infrared Thermometer, Model Number CK-T1501, CK-T1502, CK-T1503?

Infrared Thermometer, Model Number CK-T1501, CK-T1502, CK-T1503 is manufactured by Shenzhen Changkun Technology Co., Ltd..

What is the FDA product code for Infrared Thermometer, Model Number CK-T1501, CK-T1502, CK-T1503?

The FDA product code for Infrared Thermometer, Model Number CK-T1501, CK-T1502, CK-T1503 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)

Other Devices by Shenzhen Changkun Technology Co., Ltd.

K193386Wrist Electronic Sphygmomanometer K193387Arm Electronic Sphygmomanometer K231595Electric Breast Pump K221798Finger Pulse Oximeter, Model: X1906P K252552Pelvic Floor Rehabilitation Therapy Device (PD2301/PD2302/PD2303)

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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