AirTom
K-Number: K222466 · 2023-06-30
ApplicantBilab
Decision Date2023-06-30
Product CodeQEB
Advisory CommitteeAN
DecisionSubstantially Equivalent
Device Summary
AirTom is the device name listed in this FDA 510(k) record. The listed applicant is Bilab. It received FDA 510(k) clearance on 2023-06-30 under 510(k) number K222466. The device is classified under product code QEB. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the AirTom?
AirTom is a medical device that received FDA 510(k) clearance on 2023-06-30. The listed applicant is Bilab. The 510(k) number is K222466.
When did AirTom receive FDA 510(k) clearance?
AirTom received FDA 510(k) clearance on 2023-06-30, under 510(k) number K222466.
Who is the listed applicant for AirTom?
The FDA 510(k) record lists Bilab as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for AirTom?
The FDA product code for AirTom is QEB.
Related Devices (Code: QEB)
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
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