FDA 510(k)

Aulisa Temperature Module (TM0002)

Número K: K240220 · 2024-09-27

RequerenteTaiwan Aulisa Medical Devices Technologies, Inc.

Data da decisão2024-09-27

Código do produtoFLL

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do 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.

Perguntas frequentes

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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Outros registros que listam Taiwan Aulisa Medical Devices Technologies, Inc. como candidato(a)

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 os 9 dispositivos →

Dispositivos Relacionados (Código: FLL)

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Fonte oficial

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