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FDA 510(k)

TRULY INFRARED EAR THERMOMETER, MODEL TET-350, TET-360, TET-370

K-Number: K090564 · 2009-06-24

ApplicantTruly Instrument Limited
Decision Date2009-06-24
Product CodeFLL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

TRULY INFRARED EAR THERMOMETER, MODEL TET-350, TET-360, TET-370 is the device name listed in this FDA 510(k) record. The listed applicant is Truly Instrument Limited. It received FDA 510(k) clearance on 2009-06-24 under 510(k) number K090564. 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 TRULY INFRARED EAR THERMOMETER, MODEL TET-350, TET-360, TET-370?

TRULY INFRARED EAR THERMOMETER, MODEL TET-350, TET-360, TET-370 is a medical device that received FDA 510(k) clearance on 2009-06-24. The listed applicant is Truly Instrument Limited. The 510(k) number is K090564.

When did TRULY INFRARED EAR THERMOMETER, MODEL TET-350, TET-360, TET-370 receive FDA 510(k) clearance?

TRULY INFRARED EAR THERMOMETER, MODEL TET-350, TET-360, TET-370 received FDA 510(k) clearance on 2009-06-24, under 510(k) number K090564.

Who is the listed applicant for TRULY INFRARED EAR THERMOMETER, MODEL TET-350, TET-360, TET-370?

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

What is the FDA product code for TRULY INFRARED EAR THERMOMETER, MODEL TET-350, TET-360, TET-370?

The FDA product code for TRULY INFRARED EAR THERMOMETER, MODEL TET-350, TET-360, TET-370 is FLL.

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Other records listing Truly Instrument Limited 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.

K220276Infrared Thermometer TET-351K192023Arm Blood Pressure MonitorK161846Automatic Arm Bluetooth Blood Pressure MonitorK081852TRULY AUTOMATIC BLOOD PRESSURE MONITOR, MODEL DB11

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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