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FDA 510(k)

VDT985US Vicks SmartTemp Thermometer

K-Number: K152975 · 2016-03-23

ApplicantKaz USA, Inc., A Helen of Troy Company
Decision Date2016-03-23
Product CodeFLL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

VDT985US Vicks SmartTemp 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 2016-03-23 under 510(k) number K152975. 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 VDT985US Vicks SmartTemp Thermometer?

VDT985US Vicks SmartTemp Thermometer is a medical device that received FDA 510(k) clearance on 2016-03-23. The listed applicant is Kaz USA, Inc., A Helen of Troy Company. The 510(k) number is K152975.

When did VDT985US Vicks SmartTemp Thermometer receive FDA 510(k) clearance?

VDT985US Vicks SmartTemp Thermometer received FDA 510(k) clearance on 2016-03-23, under 510(k) number K152975.

Who is the listed applicant for VDT985US Vicks SmartTemp 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 VDT985US Vicks SmartTemp Thermometer?

The FDA product code for VDT985US Vicks SmartTemp Thermometer is FLL.

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

K212609BHA100 Series Braun Clear Hearing AidK193213Vicks VNT200 No Touch Forehead ThermometerK180131Vicks RapidRead Digital ThermometerK181242Braun BNT400 No Touch + Forehead ThermometerK181015Braun BFH175 Infrared Forehead ThermometerK163516Braun No Touch + Forehead NTF3000 Thermometer

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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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