FDA 510(k)

Guardian Angel Rx GA2001 Digital Vital Sign Monitoring System

Numéro K : K191207 · 2019-06-25

DemandeurTaiwan Aulisa Medical Devices Technologies, Inc.

Date de décision2019-06-25

Code produitDQA

Comité consultatifCV

DécisionSubstantially Equivalent

Résumé du dispositif

Guardian Angel Rx GA2001 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 2019-06-25 under 510(k) number K191207. The device is classified under product code DQA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the Guardian Angel Rx GA2001 Digital Vital Sign Monitoring System?

Guardian Angel Rx GA2001 Digital Vital Sign Monitoring System is a medical device that received FDA 510(k) clearance on 2019-06-25. The listed applicant is Taiwan Aulisa Medical Devices Technologies, Inc.. The 510(k) number is K191207.

When did Guardian Angel Rx GA2001 Digital Vital Sign Monitoring System receive FDA 510(k) clearance?

Guardian Angel Rx GA2001 Digital Vital Sign Monitoring System received FDA 510(k) clearance on 2019-06-25, under 510(k) number K191207.

Who is the listed applicant for Guardian Angel Rx GA2001 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 GA2001 Digital Vital Sign Monitoring System?

The FDA product code for Guardian Angel Rx GA2001 Digital Vital Sign Monitoring System is DQA.

Essais cliniques associés

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Autres dossiers indiquant Taiwan Aulisa Medical Devices Technologies, Inc. en tant que demandeur

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 K183067Guardian Angel Rx GA2000 Digital Vital Sign Monitoring System

Voir tous les 9 dispositifs →

Dispositifs connexes (Code : 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 Oxymètre de Pouls (SP61)Avita Corporation K252805YUWELL® Finger Pulse Oximeter (YX105, YX106, YX110, YX310)Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.

Source officielle

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