AIO Breathe
K-Number: K252525 · 2025-11-06
ApplicantAiomega, LLC
Decision Date2025-11-06
Product CodeLRK
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
AIO Breathe is a medical device manufactured by Aiomega, LLC. It received FDA 510(k) clearance on 2025-11-06 under approval number K252525. The device is classified under product code LRK. 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 2025-11-06. It is manufactured by Aiomega, LLC. The 510(k) number is K252525.
When was AIO Breathe approved by the FDA?
AIO Breathe received FDA 510(k) clearance on 2025-11-06, under approval number K252525.
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 LRK.
Other Devices by Aiomega, LLC
Related Devices (Code: LRK)
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.