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FDA 510(k)

Guardian Angel Rx GA2001 Digital Vital Sign Monitoring System

K-Number: K191207 · 2019-06-25

ApplicantTaiwan Aulisa Medical Devices Technologies, Inc.
Decision Date2019-06-25
Product CodeDQA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

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.

Frequently Asked Questions

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.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT06415656VitalTraq for the Detection of CRSCOMPLETEDNCT07186738Study of a Patient Cohort Following Digestive Surgical Care After the Implementation of a Telemonitoring and Tele-coordination Platform for Medical, Paramedical, and Social ManagementRECRUITINGNCT07622485In-Hospital Wearable-Based Monitoring Versus Standard Care in Cardiovascular Disease (INSPIRE)NOT_YET_RECRUITING

Other records listing Taiwan Aulisa Medical Devices Technologies, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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 SystemK202497Aulisa Multiple Patient Digital Vital Sign Monitoring SystemK183067Guardian Angel Rx GA2000 Digital Vital Sign Monitoring System

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Related Devices (Code: DQA)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252821Reusable Adult SpO2 Clip Sensor (3m) (M1196A); Reusable Adult SpO2 Clip Sensor (0.9m) (M1196T)Philips Medizin Systeme Böblingen GmbHK252655Pulse 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 SystemeK260931Unimed Reusable Finger Clip SpO2 Sensors (U403-49R and U103-49R)Unimed Medical Supplies, Inc.K252448AViTA Pulse Oximeter (SP61)Avita CorporationK252805YUWELL® Finger Pulse Oximeter (YX105, YX106, YX110, YX310)Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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