FDA 510(k)

Non-contact Infrared Thermometer, Models JXB-315, JXB-319, JXB-320, JXB-311

Numéro K : K213082 · 2022-01-28

DemandeurGuangzhou Berrcom Medical Device Co., Ltd.

Date de décision2022-01-28

Code produitFLL

Comité consultatifHO

DécisionSubstantially Equivalent

Résumé du dispositif

Non-contact Infrared Thermometer, Models JXB-315, JXB-319, JXB-320, JXB-311 is the device name listed in this FDA 510(k) record. The listed applicant is Guangzhou Berrcom Medical Device Co., Ltd.. It received FDA 510(k) clearance on 2022-01-28 under 510(k) number K213082. 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 Non-contact Infrared Thermometer, Models JXB-315, JXB-319, JXB-320, JXB-311?

Non-contact Infrared Thermometer, Models JXB-315, JXB-319, JXB-320, JXB-311 is a medical device that received FDA 510(k) clearance on 2022-01-28. The listed applicant is Guangzhou Berrcom Medical Device Co., Ltd.. The 510(k) number is K213082.

When did Non-contact Infrared Thermometer, Models JXB-315, JXB-319, JXB-320, JXB-311 receive FDA 510(k) clearance?

Non-contact Infrared Thermometer, Models JXB-315, JXB-319, JXB-320, JXB-311 received FDA 510(k) clearance on 2022-01-28, under 510(k) number K213082.

Who is the listed applicant for Non-contact Infrared Thermometer, Models JXB-315, JXB-319, JXB-320, JXB-311?

The FDA 510(k) record lists Guangzhou Berrcom Medical Device Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Non-contact Infrared Thermometer, Models JXB-315, JXB-319, JXB-320, JXB-311?

The FDA product code for Non-contact Infrared Thermometer, Models JXB-315, JXB-319, JXB-320, JXB-311 is FLL.

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Autres dossiers indiquant Guangzhou Berrcom Medical Device Co., Ltd. en tant que demandeur

K214077Digital Thermometer, Model: DT007, DT008 K213746Digital thermometer, Model DT101, DT102 K213084Ear Thermometer, Model ET005, ET008, ET009 K213079Ear Thermometer, Model ET001 K191570Infrared Thermometer Model MD-H30

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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