Aer X
K-Number: K200496 · 2020-07-24
Applicant3B Medical, Inc.
Decision Date2020-07-24
Product CodeCAW
Advisory CommitteeAN
DecisionSubstantially Equivalent
Device Summary
Aer X is a medical device manufactured by 3B Medical, Inc.. It received FDA 510(k) clearance on 2020-07-24 under approval number K200496. The device is classified under product code CAW. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Aer X?
Aer X is a medical device that received FDA 510(k) clearance on 2020-07-24. It is manufactured by 3B Medical, Inc.. The 510(k) number is K200496.
When was Aer X approved by the FDA?
Aer X received FDA 510(k) clearance on 2020-07-24, under approval number K200496.
What company makes Aer X?
Aer X is manufactured by 3B Medical, Inc..
What is the FDA product code for Aer X?
The FDA product code for Aer X is CAW.
Other Devices by 3B Medical, Inc.
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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.