510(k) K222466
- Device
- AirTom
- Applicant
- Bilab
- 510(k) number
- K222466
- Product code
- QEB
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2023-06-30
- Date received
- 2022-08-16
- Regulation
- 868.1505
- Classification name
- Ventilatory Electrical Impedance Tomograph
- Medical specialty
- Anesthesiology
- Review panel
- Anesthesiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Sang Keun Lee
- Address
- 5f Ubiquoss Bldg., 68 Pangyo-Ro 255beon-Gil, Bundang-Gu Seongnam-Si KR 13486 13486
FDA Registration Numbers#
- 3029845
- 3016509761
- 3004149774
- 3013853674