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FDA 510(k)

Infrared Forehead Thermometer, model: HS-9802D

K-Number: K213038 · 2022-03-10

ApplicantJiaxing Shangjia Intelligence Technology Co., Ltd.
Decision Date2022-03-10
Product CodeFLL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Infrared Forehead Thermometer, model: HS-9802D is the device name listed in this FDA 510(k) record. The listed applicant is Jiaxing Shangjia Intelligence Technology Co., Ltd.. It received FDA 510(k) clearance on 2022-03-10 under 510(k) number K213038. 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 Forehead Thermometer, model: HS-9802D?

Infrared Forehead Thermometer, model: HS-9802D is a medical device that received FDA 510(k) clearance on 2022-03-10. The listed applicant is Jiaxing Shangjia Intelligence Technology Co., Ltd.. The 510(k) number is K213038.

When did Infrared Forehead Thermometer, model: HS-9802D receive FDA 510(k) clearance?

Infrared Forehead Thermometer, model: HS-9802D received FDA 510(k) clearance on 2022-03-10, under 510(k) number K213038.

Who is the listed applicant for Infrared Forehead Thermometer, model: HS-9802D?

The FDA 510(k) record lists Jiaxing Shangjia Intelligence Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Infrared Forehead Thermometer, model: HS-9802D?

The FDA product code for Infrared Forehead Thermometer, model: HS-9802D is FLL.

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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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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