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FDA 510(k)

COTRONIC DIGITAL THERMOMETER

K-Number: K103407 · 2011-05-13

ApplicantCotronic Manufacturing
Decision Date2011-05-13
Product CodeFLL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

COTRONIC DIGITAL THERMOMETER is the device name listed in this FDA 510(k) record. The listed applicant is Cotronic Manufacturing. It received FDA 510(k) clearance on 2011-05-13 under 510(k) number K103407. 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 COTRONIC DIGITAL THERMOMETER?

COTRONIC DIGITAL THERMOMETER is a medical device that received FDA 510(k) clearance on 2011-05-13. The listed applicant is Cotronic Manufacturing. The 510(k) number is K103407.

When did COTRONIC DIGITAL THERMOMETER receive FDA 510(k) clearance?

COTRONIC DIGITAL THERMOMETER received FDA 510(k) clearance on 2011-05-13, under 510(k) number K103407.

Who is the listed applicant for COTRONIC DIGITAL THERMOMETER?

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

What is the FDA product code for COTRONIC DIGITAL THERMOMETER?

The FDA product code for COTRONIC DIGITAL THERMOMETER 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 Cotronic Manufacturing 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.

K032434CLINICAL ELECTRONIC THERMOMETER

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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