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FDA 510(k)

INFARED EAR THERMOMETER, MODEL TH8 SERIES

K-Number: K011059 · 2001-09-17

ApplicantRadiant Innovation, Inc.
Decision Date2001-09-17
Product CodeFLL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

INFARED EAR THERMOMETER, MODEL TH8 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 2001-09-17 under 510(k) number K011059. 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 INFARED EAR THERMOMETER, MODEL TH8 SERIES?

INFARED EAR THERMOMETER, MODEL TH8 SERIES is a medical device that received FDA 510(k) clearance on 2001-09-17. The listed applicant is Radiant Innovation, Inc.. The 510(k) number is K011059.

When did INFARED EAR THERMOMETER, MODEL TH8 SERIES receive FDA 510(k) clearance?

INFARED EAR THERMOMETER, MODEL TH8 SERIES received FDA 510(k) clearance on 2001-09-17, under 510(k) number K011059.

Who is the listed applicant for INFARED EAR THERMOMETER, MODEL TH8 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 INFARED EAR THERMOMETER, MODEL TH8 SERIES?

The FDA product code for INFARED EAR THERMOMETER, MODEL TH8 SERIES is FLL.

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Other records listing Radiant Innovation, Inc. as applicant

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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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