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

FDA 510(k)

Non-contact Infrared Body Thermometer, Model HTD8808C, HTD8818A, HTD8816C

K-Number: K203332 · 2021-02-25

ApplicantHetaida Technology Co., Ltd.
Decision Date2021-02-25
Product CodeFLL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Non-contact Infrared Body Thermometer, Model HTD8808C, HTD8818A, HTD8816C is a medical device manufactured by Hetaida Technology Co., Ltd.. It received FDA 510(k) clearance on 2021-02-25 under approval number K203332. 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 Body Thermometer, Model HTD8808C, HTD8818A, HTD8816C?

Non-contact Infrared Body Thermometer, Model HTD8808C, HTD8818A, HTD8816C is a medical device that received FDA 510(k) clearance on 2021-02-25. It is manufactured by Hetaida Technology Co., Ltd.. The 510(k) number is K203332.

When was Non-contact Infrared Body Thermometer, Model HTD8808C, HTD8818A, HTD8816C approved by the FDA?

Non-contact Infrared Body Thermometer, Model HTD8808C, HTD8818A, HTD8816C received FDA 510(k) clearance on 2021-02-25, under approval number K203332.

What company makes Non-contact Infrared Body Thermometer, Model HTD8808C, HTD8818A, HTD8816C?

Non-contact Infrared Body Thermometer, Model HTD8808C, HTD8818A, HTD8816C is manufactured by Hetaida Technology Co., Ltd..

What is the FDA product code for Non-contact Infrared Body Thermometer, Model HTD8808C, HTD8818A, HTD8816C?

The FDA product code for Non-contact Infrared Body Thermometer, Model HTD8808C, HTD8818A, HTD8816C is FLL.

Related Clinical Trials

NCT07034521 The Feasibility and Therapeutic Effect of Hybrid End-effector Robot-assisted Gait Training With an Active-assisted Module in Chronic Stroke Survivors RECRUITING NCT05535738 Using a Contact Dermatitis Model With Biologic Medications to Study Skin Inflammation ACTIVE_NOT_RECRUITING NCT07231653 Home Monitoring Study for Surgical Patients NOT_YET_RECRUITING

Other Devices by Hetaida Technology Co., Ltd.

K171888Non-contact infrared body thermometer K180385Infrared Body Thermometer K180387Infrared Ear Thermometer K200159Non-contact Infrared Body Thermometer, model:HTD8823US K223170Electronic Blood Pressure Monitor, model: HTD6602US K241202Electric nasal aspirator (HTD2601US)

View all 8 devices →

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.

↑