EleGARD
K-Number: K221901 · 2022-07-29
ApplicantAdvancedcpr Solutions, LLC
Decision Date2022-07-29
Product CodeFOA
Advisory CommitteeHO
DecisionSubstantially Equivalent
Device Summary
EleGARD is a medical device manufactured by Advancedcpr Solutions, LLC. It received FDA 510(k) clearance on 2022-07-29 under approval number K221901. The device is classified under product code FOA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the EleGARD?
EleGARD is a medical device that received FDA 510(k) clearance on 2022-07-29. It is manufactured by Advancedcpr Solutions, LLC. The 510(k) number is K221901.
When was EleGARD approved by the FDA?
EleGARD received FDA 510(k) clearance on 2022-07-29, under approval number K221901.
What company makes EleGARD?
EleGARD is manufactured by Advancedcpr Solutions, LLC.
What is the FDA product code for EleGARD?
The FDA product code for EleGARD is FOA.
Related Devices (Code: FOA)
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.