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FDA 510(k)

Guardian Angel Rx GA 1001 Digital Vital Sign Monitoring System

K-Number: K182822 · 2019-03-01

ApplicantTaiwan Aulisa Medical Devices Technologies, Inc.
Decision Date2019-03-01
Product CodeDQA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Guardian Angel Rx GA 1001 Digital Vital Sign Monitoring System is a medical device manufactured by Taiwan Aulisa Medical Devices Technologies, Inc.. It received FDA 510(k) clearance on 2019-03-01 under approval number K182822. 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 GA 1001 Digital Vital Sign Monitoring System?

Guardian Angel Rx GA 1001 Digital Vital Sign Monitoring System is a medical device that received FDA 510(k) clearance on 2019-03-01. It is manufactured by Taiwan Aulisa Medical Devices Technologies, Inc.. The 510(k) number is K182822.

When was Guardian Angel Rx GA 1001 Digital Vital Sign Monitoring System approved by the FDA?

Guardian Angel Rx GA 1001 Digital Vital Sign Monitoring System received FDA 510(k) clearance on 2019-03-01, under approval number K182822.

What company makes Guardian Angel Rx GA 1001 Digital Vital Sign Monitoring System?

Guardian Angel Rx GA 1001 Digital Vital Sign Monitoring System is manufactured by Taiwan Aulisa Medical Devices Technologies, Inc..

What is the FDA product code for Guardian Angel Rx GA 1001 Digital Vital Sign Monitoring System?

The FDA product code for Guardian Angel Rx GA 1001 Digital Vital Sign Monitoring System is DQA.

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Other Devices by Taiwan Aulisa Medical Devices Technologies, Inc.

K162580Guardian Angel GA1000 Digital Vital Sign Monitoring System K191207Guardian Angel Rx GA2001 Digital Vital Sign Monitoring System K183067Guardian Angel Rx GA2000 Digital Vital Sign Monitoring System K202497Aulisa Multiple Patient Digital Vital Sign Monitoring System K203208Guardian Angel Rx GA2000 Series Digital Vital Sign Monitoring System K240220Aulisa Temperature Module (TM0002)

View all 9 devices →

Related Devices (Code: DQA)

K162675Masimo Rainbow SET Intellivue Module Pulse CO-OximeterMasimo Corporation K160231Model X-100C CO-Met™ Oximetry SystemNonin Medical, Inc. K160940Masimo Disposable Transflectance Forehead SensorMasimo Corporation K153021Fingertip Pulse Oximeter A310Amemo, Inc. K160268Fingertip Pulse Oximeter MD300CG11/MD300CG51Beijing Choice Electronic Technology Co., Ltd. K161560Fingertip Pulse Oximeter MD300CN310Beijing Choice Electronic Technology 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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