Decision Date2018-11-28
Product CodeFLL
Advisory CommitteeHO
DecisionSubstantially Equivalent
Device Summary
Non-contact Infrared Thermometer is the device name listed in this FDA 510(k) record. The listed applicant is Alicn Medical (Shenzhen), Inc.. It received FDA 510(k) clearance on 2018-11-28 under 510(k) number K180207. 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 Non-contact Infrared Thermometer?
Non-contact Infrared Thermometer is a medical device that received FDA 510(k) clearance on 2018-11-28. The listed applicant is Alicn Medical (Shenzhen), Inc.. The 510(k) number is K180207.
When did Non-contact Infrared Thermometer receive FDA 510(k) clearance?
Non-contact Infrared Thermometer received FDA 510(k) clearance on 2018-11-28, under 510(k) number K180207.
Who is the listed applicant for Non-contact Infrared Thermometer?
The FDA 510(k) record lists Alicn Medical (Shenzhen), Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Non-contact Infrared Thermometer?
The FDA product code for Non-contact Infrared Thermometer is FLL.
Other records listing Alicn Medical (Shenzhen), Inc. 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.
K232338Electronic Thermometer, Model: AET-F331, AET-F332, AET-F333, AET-F344, AET-F345, AET-F346, AET-F354, AET-F355, AET-F356, AET-F361, AET-F362, AET-F363, AET-F371, AET-F372, AET-F373, AET-F381, AET-F382, AET-F383K231050Arm Blood Pressure MonitorK230649Arm Blood Pressure MonitorK222248Infrared ThermometerK221913Arm Blood Pressure MonitorK210937Electronic Thermometer, Model: AET-F101, AET-F221, AET-F231, AET-F241 View all 13 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.