FDA 510(k)

Temp Pal (Smart Thermometer Patch) Model Number: STP-MB01-1

N.º K: K222588 · 2023-02-17

Fecha de decisión2023-02-17

Código de productoFLL

Comité asesorHO

DecisiónSubstantially Equivalent

Resumen del dispositivo

Temp Pal (Smart Thermometer Patch) Model Number: STP-MB01-1 is the device name listed in this FDA 510(k) record. The listed applicant is Iweecare Co., Ltd.. It received FDA 510(k) clearance on 2023-02-17 under 510(k) number K222588. The device is classified under product code FLL. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Temp Pal (Smart Thermometer Patch) Model Number: STP-MB01-1?

Temp Pal (Smart Thermometer Patch) Model Number: STP-MB01-1 is a medical device that received FDA 510(k) clearance on 2023-02-17. The listed applicant is Iweecare Co., Ltd.. The 510(k) number is K222588.

When did Temp Pal (Smart Thermometer Patch) Model Number: STP-MB01-1 receive FDA 510(k) clearance?

Temp Pal (Smart Thermometer Patch) Model Number: STP-MB01-1 received FDA 510(k) clearance on 2023-02-17, under 510(k) number K222588.

Who is the listed applicant for Temp Pal (Smart Thermometer Patch) Model Number: STP-MB01-1?

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

What is the FDA product code for Temp Pal (Smart Thermometer Patch) Model Number: STP-MB01-1?

The FDA product code for Temp Pal (Smart Thermometer Patch) Model Number: STP-MB01-1 is FLL.

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Otros registros que enlistan a Iweecare Co., Ltd. como solicitante

K202603Temp Pal

Dispositivos relacionados (Código: FLL)

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.

Fuente oficial

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