FDA 510(k)

AIO Breathe

K-Number: K233754 · 2024-02-23

Decision Date2024-02-23

Product CodeLQZ

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

AIO Breathe is the device name listed in this FDA 510(k) record. The listed applicant is Aiomega, LLC. It received FDA 510(k) clearance on 2024-02-23 under 510(k) 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. The listed applicant is Aiomega, LLC. The 510(k) number is K233754.

When did AIO Breathe receive FDA 510(k) clearance?

AIO Breathe received FDA 510(k) clearance on 2024-02-23, under 510(k) number K233754.

Who is the listed applicant for AIO Breathe?

The FDA 510(k) record lists Aiomega, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AIO Breathe?

The FDA product code for AIO Breathe is LQZ.

Other records listing Aiomega, LLC 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.

K252525AIO Breathe

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.