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FDA 510(k)

ELECTRONIC CLINICAL THERMOMETER

K-Number: K831718 · 1983-07-12

ApplicantMitteloy
Decision Date1983-07-12
Product CodeFLL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

ELECTRONIC CLINICAL THERMOMETER is the device name listed in this FDA 510(k) record. The listed applicant is Mitteloy. It received FDA 510(k) clearance on 1983-07-12 under 510(k) number K831718. 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 CLINICAL THERMOMETER?

ELECTRONIC CLINICAL THERMOMETER is a medical device that received FDA 510(k) clearance on 1983-07-12. The listed applicant is Mitteloy. The 510(k) number is K831718.

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

ELECTRONIC CLINICAL THERMOMETER received FDA 510(k) clearance on 1983-07-12, under 510(k) number K831718.

Who is the listed applicant for ELECTRONIC CLINICAL THERMOMETER?

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

What is the FDA product code for ELECTRONIC CLINICAL THERMOMETER?

The FDA product code for ELECTRONIC CLINICAL 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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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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