Aer X
K-Number: K200496 · 2020-07-24
Device Summary
Frequently Asked Questions
What is the Aer X?
Aer X is a medical device that received FDA 510(k) clearance on 2020-07-24. The listed applicant is 3B Medical, Inc.. The 510(k) number is K200496.
When did Aer X receive FDA 510(k) clearance?
Aer X received FDA 510(k) clearance on 2020-07-24, under 510(k) number K200496.
Who is the listed applicant for Aer X?
The FDA 510(k) record lists 3B Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Aer X?
The FDA product code for Aer X is CAW.
Other records listing 3B Medical, Inc. as applicant
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
Related Devices (Code: CAW)
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
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.