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)

RII INFRARED EAR THERMOMETER, MODELS TH00XY SERIES

K-Number: K051269 · 2005-09-09

ApplicantRadiant Innovation, Inc.
Decision Date2005-09-09
Product CodeFLL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

RII INFRARED EAR THERMOMETER, MODELS TH00XY SERIES is the device name listed in this FDA 510(k) record. The listed applicant is Radiant Innovation, Inc.. It received FDA 510(k) clearance on 2005-09-09 under 510(k) number K051269. 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 RII INFRARED EAR THERMOMETER, MODELS TH00XY SERIES?

RII INFRARED EAR THERMOMETER, MODELS TH00XY SERIES is a medical device that received FDA 510(k) clearance on 2005-09-09. The listed applicant is Radiant Innovation, Inc.. The 510(k) number is K051269.

When did RII INFRARED EAR THERMOMETER, MODELS TH00XY SERIES receive FDA 510(k) clearance?

RII INFRARED EAR THERMOMETER, MODELS TH00XY SERIES received FDA 510(k) clearance on 2005-09-09, under 510(k) number K051269.

Who is the listed applicant for RII INFRARED EAR THERMOMETER, MODELS TH00XY SERIES?

The FDA 510(k) record lists Radiant Innovation, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RII INFRARED EAR THERMOMETER, MODELS TH00XY SERIES?

The FDA product code for RII INFRARED EAR THERMOMETER, MODELS TH00XY SERIES 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Radiant Innovation, 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.

K240648Non-contact Forehead Thermomete (TH48FE, TH09F, THD2FE)K163601RII Smart IR ThermometerK162083RII Multi-function Infrared Thermometer, Model TH52ZK121428NON-CONTACT CLINICAL THERMOMETERK111637INFRARED EAR THERMOMETERK103097INFRARED EAR THERMOMETER

View all 15 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.

↑