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)

Non Contact Infrared Forehead Thermometer

K-Number: K170662 · 2017-11-22

ApplicantIntrinity Global Limited
Decision Date2017-11-22
Product CodeFLL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Non Contact Infrared Forehead Thermometer is the device name listed in this FDA 510(k) record. The listed applicant is Intrinity Global Limited. It received FDA 510(k) clearance on 2017-11-22 under 510(k) number K170662. 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 Forehead Thermometer?

Non Contact Infrared Forehead Thermometer is a medical device that received FDA 510(k) clearance on 2017-11-22. The listed applicant is Intrinity Global Limited. The 510(k) number is K170662.

When did Non Contact Infrared Forehead Thermometer receive FDA 510(k) clearance?

Non Contact Infrared Forehead Thermometer received FDA 510(k) clearance on 2017-11-22, under 510(k) number K170662.

Who is the listed applicant for Non Contact Infrared Forehead Thermometer?

The FDA 510(k) record lists Intrinity Global Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Non Contact Infrared Forehead Thermometer?

The FDA product code for Non Contact Infrared Forehead Thermometer 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.

NCT07231653Home Monitoring Study for Surgical PatientsNOT_YET_RECRUITINGNCT07762053Clinical Investigation of Eye C Better's Photobionic Intraocular Pressure Biomonitor TonometerNOT_YET_RECRUITING

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.

↑