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FDA 510(k)

Vicks RapidRead Digital Thermometer

K-Number: K180131 · 2018-08-14

ApplicantKaz USA, Inc., A Helen of Troy Company
Decision Date2018-08-14
Product CodeFLL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Vicks RapidRead Digital Thermometer is the device name listed in this FDA 510(k) record. The listed applicant is Kaz USA, Inc., A Helen of Troy Company. It received FDA 510(k) clearance on 2018-08-14 under 510(k) number K180131. 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 Vicks RapidRead Digital Thermometer?

Vicks RapidRead Digital Thermometer is a medical device that received FDA 510(k) clearance on 2018-08-14. The listed applicant is Kaz USA, Inc., A Helen of Troy Company. The 510(k) number is K180131.

When did Vicks RapidRead Digital Thermometer receive FDA 510(k) clearance?

Vicks RapidRead Digital Thermometer received FDA 510(k) clearance on 2018-08-14, under 510(k) number K180131.

Who is the listed applicant for Vicks RapidRead Digital Thermometer?

The FDA 510(k) record lists Kaz USA, Inc., A Helen of Troy Company as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Vicks RapidRead Digital Thermometer?

The FDA product code for Vicks RapidRead Digital Thermometer is FLL.

Other records listing Kaz USA, Inc., A Helen of Troy Company as applicant

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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

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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