FDA 510(k)

Braun No Touch + Forehead NTF3000 Thermometer

Numéro K : K163516 · 2017-04-21

DemandeurKaz USA, Inc., A Helen of Troy Company

Date de décision2017-04-21

Code produitFLL

Comité consultatifHO

DécisionSubstantially Equivalent

Résumé du dispositif

Braun No Touch + Forehead NTF3000 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 2017-04-21 under 510(k) number K163516. The device is classified under product code FLL. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the Braun No Touch + Forehead NTF3000 Thermometer?

Braun No Touch + Forehead NTF3000 Thermometer is a medical device that received FDA 510(k) clearance on 2017-04-21. The listed applicant is Kaz USA, Inc., A Helen of Troy Company. The 510(k) number is K163516.

When did Braun No Touch + Forehead NTF3000 Thermometer receive FDA 510(k) clearance?

Braun No Touch + Forehead NTF3000 Thermometer received FDA 510(k) clearance on 2017-04-21, under 510(k) number K163516.

Who is the listed applicant for Braun No Touch + Forehead NTF3000 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 Braun No Touch + Forehead NTF3000 Thermometer?

The FDA product code for Braun No Touch + Forehead NTF3000 Thermometer is FLL.

Essais cliniques associés

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Dispositifs connexes (Code : FLL)

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.

Source officielle

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