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FDA 510(k)

Guardian Angel GA1000 Digital Vital Sign Monitoring System

K-Number: K162580 · 2017-03-03

ApplicantTaiwan Aulisa Medical Devices Technologies, Inc.
Decision Date2017-03-03
Product CodeDQA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Guardian Angel GA1000 Digital Vital Sign Monitoring System is a medical device manufactured by Taiwan Aulisa Medical Devices Technologies, Inc.. It received FDA 510(k) clearance on 2017-03-03 under approval number K162580. 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 GA1000 Digital Vital Sign Monitoring System?

Guardian Angel GA1000 Digital Vital Sign Monitoring System is a medical device that received FDA 510(k) clearance on 2017-03-03. It is manufactured by Taiwan Aulisa Medical Devices Technologies, Inc.. The 510(k) number is K162580.

When was Guardian Angel GA1000 Digital Vital Sign Monitoring System approved by the FDA?

Guardian Angel GA1000 Digital Vital Sign Monitoring System received FDA 510(k) clearance on 2017-03-03, under approval number K162580.

What company makes Guardian Angel GA1000 Digital Vital Sign Monitoring System?

Guardian Angel GA1000 Digital Vital Sign Monitoring System is manufactured by Taiwan Aulisa Medical Devices Technologies, Inc..

What is the FDA product code for Guardian Angel GA1000 Digital Vital Sign Monitoring System?

The FDA product code for Guardian Angel GA1000 Digital Vital Sign Monitoring System is DQA.

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Related PubMed Literature

PMID: 39670276 Multicenter Evaluation of Machine-Learning Continuous Pulse Rate Algorithm on Wrist-Worn Device. Digital biomarkers (2024) PMID: 37459057 Assessment of US Food and Drug Administration-Approved Digital Medical Devices for Just-in-Time Interventions: A Systematic Review. JAMA internal medicine (2023) PMID: 37181834 Methodology for Conducting Post-Marketing Surveillance of Software as a Medical Device Based on Artificial Intelligence Technologies. Sovremennye tekhnologii v meditsine (2022) PMID: 34056520 Remote Cardiac Safety Monitoring through the Lens of the FDA Biomarker Qualification Evidentiary Criteria Framework: A Case Study Analysis. Digital biomarkers (2021)

Other Devices by Taiwan Aulisa Medical Devices Technologies, Inc.

K191207Guardian Angel Rx GA2001 Digital Vital Sign Monitoring System K182822Guardian Angel Rx GA 1001 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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