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FDA 510(k)

ELECTRONIC DIGITAL THERMOMETER

K-Number: K885308 · 1989-03-16

ApplicantEwig Industries Co. , Ltd.
Decision Date1989-03-16
Product CodeFLL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

ELECTRONIC DIGITAL THERMOMETER is the device name listed in this FDA 510(k) record. The listed applicant is Ewig Industries Co. , Ltd.. It received FDA 510(k) clearance on 1989-03-16 under 510(k) number K885308. 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 ELECTRONIC DIGITAL THERMOMETER?

ELECTRONIC DIGITAL THERMOMETER is a medical device that received FDA 510(k) clearance on 1989-03-16. The listed applicant is Ewig Industries Co. , Ltd.. The 510(k) number is K885308.

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

ELECTRONIC DIGITAL THERMOMETER received FDA 510(k) clearance on 1989-03-16, under 510(k) number K885308.

Who is the listed applicant for ELECTRONIC DIGITAL THERMOMETER?

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

What is the FDA product code for ELECTRONIC DIGITAL THERMOMETER?

The FDA product code for ELECTRONIC DIGITAL 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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