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FDA 510(k)

Infrared Thermometer Model MD-H30

K-Number: K191570 · 2019-11-13

ApplicantGuangzhou Berrcom Medical Device Co., Ltd.
Decision Date2019-11-13
Product CodeFLL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Infrared Thermometer Model MD-H30 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 2019-11-13 under 510(k) number K191570. 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 Infrared Thermometer Model MD-H30?

Infrared Thermometer Model MD-H30 is a medical device that received FDA 510(k) clearance on 2019-11-13. The listed applicant is Guangzhou Berrcom Medical Device Co., Ltd.. The 510(k) number is K191570.

When did Infrared Thermometer Model MD-H30 receive FDA 510(k) clearance?

Infrared Thermometer Model MD-H30 received FDA 510(k) clearance on 2019-11-13, under 510(k) number K191570.

Who is the listed applicant for Infrared Thermometer Model MD-H30?

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 Infrared Thermometer Model MD-H30?

The FDA product code for Infrared Thermometer Model MD-H30 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 ET001K213082Non-contact Infrared Thermometer, Models JXB-315, JXB-319, JXB-320, JXB-311

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

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