Guardian Angel Rx GA2001 Digital Vital Sign Monitoring System
K-Number: K191207 · 2019-06-25
Decision Date2019-06-25
Product CodeDQA
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
Guardian Angel Rx GA2001 Digital Vital Sign Monitoring System is a medical device manufactured by Taiwan Aulisa Medical Devices Technologies, Inc.. It received FDA 510(k) clearance on 2019-06-25 under approval 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. It is manufactured by Taiwan Aulisa Medical Devices Technologies, Inc.. The 510(k) number is K191207.
When was Guardian Angel Rx GA2001 Digital Vital Sign Monitoring System approved by the FDA?
Guardian Angel Rx GA2001 Digital Vital Sign Monitoring System received FDA 510(k) clearance on 2019-06-25, under approval number K191207.
What company makes Guardian Angel Rx GA2001 Digital Vital Sign Monitoring System?
Guardian Angel Rx GA2001 Digital Vital Sign Monitoring System is manufactured by Taiwan Aulisa Medical Devices Technologies, Inc..
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.
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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.