Aurora Evacuator
K-Number: K190075 · 2019-02-12
ApplicantRebound Therapeutics
Decision Date2019-02-12
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Aurora Evacuator is a medical device manufactured by Rebound Therapeutics. It received FDA 510(k) clearance on 2019-02-12 under approval number K190075. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Aurora Evacuator?
Aurora Evacuator is a medical device that received FDA 510(k) clearance on 2019-02-12. It is manufactured by Rebound Therapeutics. The 510(k) number is K190075.
When was Aurora Evacuator approved by the FDA?
Aurora Evacuator received FDA 510(k) clearance on 2019-02-12, under approval number K190075.
What company makes Aurora Evacuator?
Aurora Evacuator is manufactured by Rebound Therapeutics.
What is the FDA product code for Aurora Evacuator?
The FDA product code for Aurora Evacuator is GEI.
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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.