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FDA 510(k)

Wireless Smart Thermometer

K-Number: K233192 · 2024-04-05

ApplicantFamidoc Technology Company Limited
Decision Date2024-04-05
Product CodeFLL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Wireless Smart Thermometer is the device name listed in this FDA 510(k) record. The listed applicant is Famidoc Technology Company Limited. It received FDA 510(k) clearance on 2024-04-05 under 510(k) number K233192. 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 Smart Thermometer?

Wireless Smart Thermometer is a medical device that received FDA 510(k) clearance on 2024-04-05. The listed applicant is Famidoc Technology Company Limited. The 510(k) number is K233192.

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

Wireless Smart Thermometer received FDA 510(k) clearance on 2024-04-05, under 510(k) number K233192.

Who is the listed applicant for Wireless Smart Thermometer?

The FDA 510(k) record lists Famidoc Technology Company Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Wireless Smart Thermometer?

The FDA product code for Wireless Smart Thermometer is FLL.

Other records listing Famidoc Technology Company Limited 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.

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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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