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FDA 510(k)

DIGITAL PACIFIER THERMOMETER (MODEL NO.: TM-03)

K-Number: K120671 · 2013-05-17

ApplicantCotronic Technology Limited
Decision Date2013-05-17
Product CodeFLL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

DIGITAL PACIFIER THERMOMETER (MODEL NO.: TM-03) is the device name listed in this FDA 510(k) record. The listed applicant is Cotronic Technology Limited. It received FDA 510(k) clearance on 2013-05-17 under 510(k) number K120671. 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 DIGITAL PACIFIER THERMOMETER (MODEL NO.: TM-03)?

DIGITAL PACIFIER THERMOMETER (MODEL NO.: TM-03) is a medical device that received FDA 510(k) clearance on 2013-05-17. The listed applicant is Cotronic Technology Limited. The 510(k) number is K120671.

When did DIGITAL PACIFIER THERMOMETER (MODEL NO.: TM-03) receive FDA 510(k) clearance?

DIGITAL PACIFIER THERMOMETER (MODEL NO.: TM-03) received FDA 510(k) clearance on 2013-05-17, under 510(k) number K120671.

Who is the listed applicant for DIGITAL PACIFIER THERMOMETER (MODEL NO.: TM-03)?

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

What is the FDA product code for DIGITAL PACIFIER THERMOMETER (MODEL NO.: TM-03)?

The FDA product code for DIGITAL PACIFIER THERMOMETER (MODEL NO.: TM-03) is FLL.

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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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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