FDA 510(k)

Guardian Angel Rx GA2000 Series Digital Vital Sign Monitoring System

Número K: K203208 · 2022-06-12

RequerenteTaiwan Aulisa Medical Devices Technologies, Inc.

Data da decisão2022-06-12

Código do produtoDQA

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

Guardian Angel Rx GA2000 Series 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 2022-06-12 under 510(k) number K203208. 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 Series Digital Vital Sign Monitoring System?

Guardian Angel Rx GA2000 Series Digital Vital Sign Monitoring System is a medical device that received FDA 510(k) clearance on 2022-06-12. The listed applicant is Taiwan Aulisa Medical Devices Technologies, Inc.. The 510(k) number is K203208.

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

Guardian Angel Rx GA2000 Series Digital Vital Sign Monitoring System received FDA 510(k) clearance on 2022-06-12, under 510(k) number K203208.

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

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

Ensaios clínicos relacionados

Registros relacionados são pareados automaticamente usando nomes, códigos de produtos ou outros metadados. Um pareamento não estabelece um vínculo clínico, científico, corporativo ou regulatório verificado; revise as fontes oficiais vinculadas.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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)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: DQA)

K252821Reusable Adult SpO2 Clip Sensor (3m) (M1196A); Reusable Adult SpO2 Clip Sensor (0.9m) (M1196T)Philips Medizin Systeme Böblingen GmbH K252655Pulse Oximeter (PO-A2AO, PO-A2AT, PO-A3AO, PO-H1AO, PO-B1AO, PO-C5AO, PO-C5AT, PO-C6AO, PO-C6AT)Shenzhen Imdk Medical Technology Co., Ltd.K253887Nasal Alar SpO2 Sensor (989803205381); Nasal Alar SpO2 Sensor (989803205391); Nasal Alar Sp02 Sensor (989803205401)Philips Medizin Systeme K260931Unimed Reusable Finger Clip SpO2 Sensors (U403-49R and U103-49R)Unimed Medical Supplies, Inc.K252448AViTA Oxímetro de Pulso (SP61)Avita Corporation K252805YUWELL® Finger Pulse Oximeter (YX105, YX106, YX110, YX310)Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.

Fonte oficial

Ver na base de dados da FDA →

Dados provenientes da FDA Open API. Para informações mais recentes e oficiais, consulte sempre o registro oficial.