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FDA 510(k)

GEON DIGITAL CLINICAL THERMOMETER

K-Number: K003223 · 2001-01-12

ApplicantGeon Corp.
Decision Date2001-01-12
Product CodeFLL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

GEON DIGITAL CLINICAL THERMOMETER is the device name listed in this FDA 510(k) record. The listed applicant is Geon Corp.. It received FDA 510(k) clearance on 2001-01-12 under 510(k) number K003223. 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 GEON DIGITAL CLINICAL THERMOMETER?

GEON DIGITAL CLINICAL THERMOMETER is a medical device that received FDA 510(k) clearance on 2001-01-12. The listed applicant is Geon Corp.. The 510(k) number is K003223.

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

GEON DIGITAL CLINICAL THERMOMETER received FDA 510(k) clearance on 2001-01-12, under 510(k) number K003223.

Who is the listed applicant for GEON DIGITAL CLINICAL THERMOMETER?

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

What is the FDA product code for GEON DIGITAL CLINICAL THERMOMETER?

The FDA product code for GEON DIGITAL CLINICAL 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 Geon Corp. 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.

K952001GEON 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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