AeroEclipse* ONE BAN
K-Number: K200063 · 2020-07-17
Device Summary
Frequently Asked Questions
What is the AeroEclipse* ONE BAN?
AeroEclipse* ONE BAN is a medical device that received FDA 510(k) clearance on 2020-07-17. The listed applicant is Trudell Medical International. The 510(k) number is K200063.
When did AeroEclipse* ONE BAN receive FDA 510(k) clearance?
AeroEclipse* ONE BAN received FDA 510(k) clearance on 2020-07-17, under 510(k) number K200063.
Who is the listed applicant for AeroEclipse* ONE BAN?
The FDA 510(k) record lists Trudell Medical International as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for AeroEclipse* ONE BAN?
The FDA product code for AeroEclipse* ONE BAN is CAF.
Other records listing Trudell Medical International 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: CAF)
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.