Decision Date2019-10-15
Product CodeFLL
Advisory CommitteeHO
DecisionSubstantially Equivalent
Device Summary
Infared Thermometer is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Calibeur Industries Co., Ltd.. It received FDA 510(k) clearance on 2019-10-15 under 510(k) number K191251. 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 Infared Thermometer?
Infared Thermometer is a medical device that received FDA 510(k) clearance on 2019-10-15. The listed applicant is Shenzhen Calibeur Industries Co., Ltd.. The 510(k) number is K191251.
When did Infared Thermometer receive FDA 510(k) clearance?
Infared Thermometer received FDA 510(k) clearance on 2019-10-15, under 510(k) number K191251.
Who is the listed applicant for Infared Thermometer?
The FDA 510(k) record lists Shenzhen Calibeur Industries Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Infared Thermometer?
The FDA product code for Infared Thermometer is FLL.
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.