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FDA 510(k)

MONITORING EAR THERMOMETER, MODEL BTM-D1A

K-Number: K062445 · 2007-02-16

ApplicantRio Flexon Technology Co., Ltd.
Decision Date2007-02-16
Product CodeFLL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

MONITORING EAR THERMOMETER, MODEL BTM-D1A is the device name listed in this FDA 510(k) record. The listed applicant is Rio Flexon Technology Co., Ltd.. It received FDA 510(k) clearance on 2007-02-16 under 510(k) number K062445. 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 MONITORING EAR THERMOMETER, MODEL BTM-D1A?

MONITORING EAR THERMOMETER, MODEL BTM-D1A is a medical device that received FDA 510(k) clearance on 2007-02-16. The listed applicant is Rio Flexon Technology Co., Ltd.. The 510(k) number is K062445.

When did MONITORING EAR THERMOMETER, MODEL BTM-D1A receive FDA 510(k) clearance?

MONITORING EAR THERMOMETER, MODEL BTM-D1A received FDA 510(k) clearance on 2007-02-16, under 510(k) number K062445.

Who is the listed applicant for MONITORING EAR THERMOMETER, MODEL BTM-D1A?

The FDA 510(k) record lists Rio Flexon Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MONITORING EAR THERMOMETER, MODEL BTM-D1A?

The FDA product code for MONITORING EAR THERMOMETER, MODEL BTM-D1A is FLL.

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Other records listing Rio Flexon Technology Co., Ltd. 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.

K100226WIRELESS BODY TEMPERATURE MONITOR MODEL BTM-DIX SERIES (BTM-DIC,D,E,F,G & H)K081256WIRELESS BODY TEMPERATURE MONITOR, MODELS BTM-DIC, D, E, F, G AND H

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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