FDA 510(k)

Guardian Angel Rx GA2000 Digital Vital Sign Monitoring System

Número K: K183067 · 2019-03-01

RequerenteTaiwan Aulisa Medical Devices Technologies, Inc.

Data da decisão2019-03-01

Código do produtoDQA

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

Guardian Angel Rx GA2000 Digital Vital Sign Monitoring System 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 2019-03-01 under 510(k) number K183067. 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 Guardian Angel Rx GA2000 Digital Vital Sign Monitoring System?

Guardian Angel Rx GA2000 Digital Vital Sign Monitoring System is a medical device that received FDA 510(k) clearance on 2019-03-01. The listed applicant is Taiwan Aulisa Medical Devices Technologies, Inc.. The 510(k) number is K183067.

When did Guardian Angel Rx GA2000 Digital Vital Sign Monitoring System receive FDA 510(k) clearance?

Guardian Angel Rx GA2000 Digital Vital Sign Monitoring System received FDA 510(k) clearance on 2019-03-01, under 510(k) number K183067.

Who is the listed applicant for Guardian Angel Rx GA2000 Digital Vital Sign Monitoring System?

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 Guardian Angel Rx GA2000 Digital Vital Sign Monitoring System?

The FDA product code for Guardian Angel Rx GA2000 Digital Vital Sign Monitoring System is DQA.

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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)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

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