Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

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 the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Changkun Technology Co., Ltd.. It received FDA 510(k) clearance on 2020-06-17 under 510(k) 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. The listed applicant is Shenzhen Changkun Technology Co., Ltd.. The 510(k) number is K193253.

When did Infrared Thermometer, Model Number CK-T1501, CK-T1502, CK-T1503 receive FDA 510(k) clearance?

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

Who is the listed applicant for Infrared Thermometer, Model Number CK-T1501, CK-T1502, CK-T1503?

The FDA 510(k) record lists Shenzhen Changkun Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

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

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07034521The Feasibility and Therapeutic Effect of Hybrid End-effector Robot-assisted Gait Training With an Active-assisted Module in Chronic Stroke SurvivorsRECRUITING

Other records listing Shenzhen Changkun Technology Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K250070Electric breast pump (MY-375,MY-376,MY-378,MY-379,MY-380,V3)K252552Pelvic Floor Rehabilitation Therapy Device (PD2301/PD2302/PD2303)K231595Electric Breast PumpK221798Finger Pulse Oximeter, Model: X1906PK193387Arm Electronic SphygmomanometerK193386Wrist Electronic Sphygmomanometer

View all 7 devices →

Related Devices (Code: FLL)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253162Temperature probes (T2252-PG); Temperature probes (TCMA-AG); Temperature probes (TCMA-PG); Temperature probes (TMQ-DAG); Temperature probes (THP-DAG)Unimed Medical Supplies, Inc.K251160Sterile temperature probe (Model: W0001ES, W0028ES, W0101FS-A, W0101FS-P, W0099LS, W0099FS, W0099PS)Shenzhen Med-Link Electronics Tech Co., Ltd.K250470Ear Thermometer (EAR-E101); Ear Thermometer (EAR-E102); Ear Thermometer (EAR-E103)Shenzhen AOJ Medical Technology Co., Ltd.K243000Reusable Temperature Probe (T1306, T2306, T3306, T4306); Disposable Temperature Probe (T5106, T6106)Shenzhen Medke Technology Co., Ltd.K250878YUWELL® Infrared Ear Thermometer (YHT100); YUWELL® Infrared Ear Thermometer (YHT107)Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.K243082Infrared ThermometerGuangzhou Daxin Health Technology 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.

↑