AirTom— 510(k) K222466

Substantially Equivalent

Bilab

FDA 510(k) clearance K222466 for AirTom, Substantially Equivalent on 2023-06-30. Applicant: Bilab. Device class: 2.

Clearance details

Applicant: Bilab
Product code: Code QEB
Device class: Class 2
Regulation: 21 CFR 868.1505
Advisory panel: Anesthesiology
Date received: 2022-08-16
Decision date: 2023-06-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Seongnam-Si, KR

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.