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FDA 510(k)

CLINIC ELECTRONIC THERMOMETER

K-Number: K850564 · 1985-02-19

ApplicantGemini Electronics Co. , Ltd.
Decision Date1985-02-19
Product CodeFLL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

CLINIC ELECTRONIC THERMOMETER is the device name listed in this FDA 510(k) record. The listed applicant is Gemini Electronics Co. , Ltd.. It received FDA 510(k) clearance on 1985-02-19 under 510(k) number K850564. 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 CLINIC ELECTRONIC THERMOMETER?

CLINIC ELECTRONIC THERMOMETER is a medical device that received FDA 510(k) clearance on 1985-02-19. The listed applicant is Gemini Electronics Co. , Ltd.. The 510(k) number is K850564.

When did CLINIC ELECTRONIC THERMOMETER receive FDA 510(k) clearance?

CLINIC ELECTRONIC THERMOMETER received FDA 510(k) clearance on 1985-02-19, under 510(k) number K850564.

Who is the listed applicant for CLINIC ELECTRONIC THERMOMETER?

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

What is the FDA product code for CLINIC ELECTRONIC THERMOMETER?

The FDA product code for CLINIC ELECTRONIC THERMOMETER 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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