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FDA 510(k)

NON-CONTACT CLINICAL THERMOMETER

K-Number: K121428 · 2012-07-17

ApplicantRadiant Innovation, Inc.
Decision Date2012-07-17
Product CodeFLL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

NON-CONTACT CLINICAL THERMOMETER 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 2012-07-17 under 510(k) number K121428. 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 CLINICAL THERMOMETER?

NON-CONTACT CLINICAL THERMOMETER is a medical device that received FDA 510(k) clearance on 2012-07-17. The listed applicant is Radiant Innovation, Inc.. The 510(k) number is K121428.

When did NON-CONTACT CLINICAL THERMOMETER receive FDA 510(k) clearance?

NON-CONTACT CLINICAL THERMOMETER received FDA 510(k) clearance on 2012-07-17, under 510(k) number K121428.

Who is the listed applicant for NON-CONTACT CLINICAL THERMOMETER?

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 NON-CONTACT CLINICAL THERMOMETER?

The FDA product code for NON-CONTACT CLINICAL THERMOMETER is FLL.

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Other records listing Radiant Innovation, Inc. as applicant

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K240648Non-contact Forehead Thermomete (TH48FE, TH09F, THD2FE)K163601RII Smart IR ThermometerK162083RII Multi-function Infrared Thermometer, Model TH52ZK111637INFRARED EAR THERMOMETERK103097INFRARED EAR THERMOMETERK102187RII INFRARED 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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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