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FDA 510(k)

THERMOFOCUS 0800, 0900, 01500 AND 0700 SERIES

K-Number: K033790 · 2004-06-03

ApplicantTecnimed S.R.L.
Decision Date2004-06-03
Product CodeFLL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

THERMOFOCUS 0800, 0900, 01500 AND 0700 SERIES is the device name listed in this FDA 510(k) record. The listed applicant is Tecnimed S.R.L.. It received FDA 510(k) clearance on 2004-06-03 under 510(k) number K033790. 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 THERMOFOCUS 0800, 0900, 01500 AND 0700 SERIES?

THERMOFOCUS 0800, 0900, 01500 AND 0700 SERIES is a medical device that received FDA 510(k) clearance on 2004-06-03. The listed applicant is Tecnimed S.R.L.. The 510(k) number is K033790.

When did THERMOFOCUS 0800, 0900, 01500 AND 0700 SERIES receive FDA 510(k) clearance?

THERMOFOCUS 0800, 0900, 01500 AND 0700 SERIES received FDA 510(k) clearance on 2004-06-03, under 510(k) number K033790.

Who is the listed applicant for THERMOFOCUS 0800, 0900, 01500 AND 0700 SERIES?

The FDA 510(k) record lists Tecnimed S.R.L. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for THERMOFOCUS 0800, 0900, 01500 AND 0700 SERIES?

The FDA product code for THERMOFOCUS 0800, 0900, 01500 AND 0700 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.

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Other records listing Tecnimed S.R.L. 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.

K160680VisioFocus Mini, VisioFocus SmartK122412VISIOFOCUSK072108MODIFICATION TO THERMOFOCUS 0800, 0900, 01500 AND 0700 SERIES

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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