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FDA 510(k)

THERMO PAL INFRARED EAR THERMOMETER

K-Number: K112189 · 2012-01-13

ApplicantDigio2 International Co., Ltd.
Decision Date2012-01-13
Product CodeFLL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

THERMO PAL INFRARED EAR THERMOMETER is the device name listed in this FDA 510(k) record. The listed applicant is Digio2 International Co., Ltd.. It received FDA 510(k) clearance on 2012-01-13 under 510(k) number K112189. 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 THERMO PAL INFRARED EAR THERMOMETER?

THERMO PAL INFRARED EAR THERMOMETER is a medical device that received FDA 510(k) clearance on 2012-01-13. The listed applicant is Digio2 International Co., Ltd.. The 510(k) number is K112189.

When did THERMO PAL INFRARED EAR THERMOMETER receive FDA 510(k) clearance?

THERMO PAL INFRARED EAR THERMOMETER received FDA 510(k) clearance on 2012-01-13, under 510(k) number K112189.

Who is the listed applicant for THERMO PAL INFRARED EAR THERMOMETER?

The FDA 510(k) record lists Digio2 International Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for THERMO PAL INFRARED EAR THERMOMETER?

The FDA product code for THERMO PAL INFRARED EAR THERMOMETER is FLL.

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Other records listing Digio2 International 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.

K091430CARE PAL, MODEL CPW-10X

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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