FDA 510(k)

Aulisa Oximeter Module (2nd Gen.) (GA-OM0007, GA-OM0008)

Número K: K233963 · 2025-02-25

RequerenteTaiwan Aulisa Medical Devices Technologies, Inc.

Data da decisão2025-02-25

Código do produtoDQA

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

Aulisa Oximeter Module (2nd Gen.) (GA-OM0007, GA-OM0008) 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 2025-02-25 under 510(k) number K233963. The device is classified under product code DQA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Aulisa Oximeter Module (2nd Gen.) (GA-OM0007, GA-OM0008)?

Aulisa Oximeter Module (2nd Gen.) (GA-OM0007, GA-OM0008) is a medical device that received FDA 510(k) clearance on 2025-02-25. The listed applicant is Taiwan Aulisa Medical Devices Technologies, Inc.. The 510(k) number is K233963.

When did Aulisa Oximeter Module (2nd Gen.) (GA-OM0007, GA-OM0008) receive FDA 510(k) clearance?

Aulisa Oximeter Module (2nd Gen.) (GA-OM0007, GA-OM0008) received FDA 510(k) clearance on 2025-02-25, under 510(k) number K233963.

Who is the listed applicant for Aulisa Oximeter Module (2nd Gen.) (GA-OM0007, GA-OM0008)?

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 Oximeter Module (2nd Gen.) (GA-OM0007, GA-OM0008)?

The FDA product code for Aulisa Oximeter Module (2nd Gen.) (GA-OM0007, GA-OM0008) is DQA.

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

K233956Aulisa Infant Oximeter Module (2nd Gen.) (GA-OM0018)K240220Aulisa Temperature Module (TM0002)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

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Fonte oficial

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