FDA 510(k)

Aulisa Temperature Module (TM0002)

N.º K: K240220 · 2024-09-27

SolicitanteTaiwan Aulisa Medical Devices Technologies, Inc.

Fecha de decisión2024-09-27

Código de productoFLL

Comité asesorHO

DecisiónSubstantially Equivalent

Resumen del dispositivo

Aulisa Temperature Module (TM0002) is the device name listed in this FDA 510(k) record. The listed applicant is Taiwan Aulisa Medical Devices Technologies, Inc.. It received FDA 510(k) clearance on 2024-09-27 under 510(k) number K240220. 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 Aulisa Temperature Module (TM0002)?

Aulisa Temperature Module (TM0002) is a medical device that received FDA 510(k) clearance on 2024-09-27. The listed applicant is Taiwan Aulisa Medical Devices Technologies, Inc.. The 510(k) number is K240220.

When did Aulisa Temperature Module (TM0002) receive FDA 510(k) clearance?

Aulisa Temperature Module (TM0002) received FDA 510(k) clearance on 2024-09-27, under 510(k) number K240220.

Who is the listed applicant for Aulisa Temperature Module (TM0002)?

The FDA 510(k) record lists Taiwan Aulisa Medical Devices Technologies, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Aulisa Temperature Module (TM0002)?

The FDA product code for Aulisa Temperature Module (TM0002) is FLL.

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Otros registros que enlistan a Taiwan Aulisa Medical Devices Technologies, Inc. como solicitante

K233963Aulisa Oximeter Module (2nd Gen.) (GA-OM0007, GA-OM0008)K233956Aulisa Infant Oximeter Module (2nd Gen.) (GA-OM0018)K203208Guardian Angel Rx GA2000 Series Digital Vital Sign Monitoring System K202497Aulisa Multiple Patient Digital Vital Sign Monitoring System K191207Guardian Angel Rx GA2001 Digital Vital Sign Monitoring System K183067Guardian Angel Rx GA2000 Digital Vital Sign Monitoring System

Ver todos los 9 dispositivos →

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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