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FDA 510(k)

Wireless Intelligent Thermometer

K-Number: K182437 · 2019-05-05

ApplicantShenzhen Jumper Medical Equipment Co., Ltd.
Decision Date2019-05-05
Product CodeFLL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Wireless Intelligent Thermometer is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Jumper Medical Equipment Co., Ltd.. It received FDA 510(k) clearance on 2019-05-05 under 510(k) number K182437. 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 Wireless Intelligent Thermometer?

Wireless Intelligent Thermometer is a medical device that received FDA 510(k) clearance on 2019-05-05. The listed applicant is Shenzhen Jumper Medical Equipment Co., Ltd.. The 510(k) number is K182437.

When did Wireless Intelligent Thermometer receive FDA 510(k) clearance?

Wireless Intelligent Thermometer received FDA 510(k) clearance on 2019-05-05, under 510(k) number K182437.

Who is the listed applicant for Wireless Intelligent Thermometer?

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

What is the FDA product code for Wireless Intelligent Thermometer?

The FDA product code for Wireless Intelligent Thermometer is FLL.

Other records listing Shenzhen Jumper Medical Equipment 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.

K231310Electronic Blood Pressure MonitorK182871Mini TENS Therapy DeviceK182495Electronic Blood Pressure MonitorK172795Infrared ThermometerK170965Fingertip Pulse Oximeter

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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