AIO Breathe
K-Number: K233754 · 2024-02-23
ApplicantAiomega, LLC
Decision Date2024-02-23
Product CodeLQZ
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
AIO Breathe is a medical device manufactured by Aiomega, LLC. It received FDA 510(k) clearance on 2024-02-23 under approval number K233754. The device is classified under product code LQZ. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the AIO Breathe?
AIO Breathe is a medical device that received FDA 510(k) clearance on 2024-02-23. It is manufactured by Aiomega, LLC. The 510(k) number is K233754.
When was AIO Breathe approved by the FDA?
AIO Breathe received FDA 510(k) clearance on 2024-02-23, under approval number K233754.
What company makes AIO Breathe?
AIO Breathe is manufactured by Aiomega, LLC.
What is the FDA product code for AIO Breathe?
The FDA product code for AIO Breathe is LQZ.
Other Devices by Aiomega, LLC
Related Devices (Code: LQZ)
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.