Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

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

K-Number: K213082 · 2022-01-28

ApplicantGuangzhou Berrcom Medical Device Co., Ltd.
Decision Date2022-01-28
Product CodeFLL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

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.

Frequently Asked Questions

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.

Other records listing Guangzhou Berrcom Medical Device Co., Ltd. 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.

K214077Digital Thermometer, Model: DT007, DT008K213746Digital thermometer, Model DT101, DT102K213084Ear Thermometer, Model ET005, ET008, ET009K213079Ear Thermometer, Model ET001K191570Infrared Thermometer Model MD-H30

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.

↑