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FDA 510(k)

Infrared Body Thermometer

K-Number: K180385 · 2018-05-11

ApplicantHetaida Technology Co., Ltd.
Decision Date2018-05-11
Product CodeFLL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Infrared Body Thermometer is the device name listed in this FDA 510(k) record. The listed applicant is Hetaida Technology Co., Ltd.. It received FDA 510(k) clearance on 2018-05-11 under 510(k) number K180385. 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 Body Thermometer?

Infrared Body Thermometer is a medical device that received FDA 510(k) clearance on 2018-05-11. The listed applicant is Hetaida Technology Co., Ltd.. The 510(k) number is K180385.

When did Infrared Body Thermometer receive FDA 510(k) clearance?

Infrared Body Thermometer received FDA 510(k) clearance on 2018-05-11, under 510(k) number K180385.

Who is the listed applicant for Infrared Body Thermometer?

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

What is the FDA product code for Infrared Body Thermometer?

The FDA product code for Infrared Body Thermometer is FLL.

Other records listing Hetaida 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.

K243661Electronic Blood Pressure MonitorK241202Electric nasal aspirator (HTD2601US)K223170Electronic Blood Pressure Monitor, model: HTD6602USK203332Non-contact Infrared Body Thermometer, Model HTD8808C, HTD8818A, HTD8816CK200159Non-contact Infrared Body Thermometer, model:HTD8823USK180387Infrared Ear Thermometer

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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.

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