FDA 510(k) Application Details - K222466

Device Classification Name	More FDA Info for this Device
510(K) Number	K222466
Device Name	AirTom
Applicant	Bilab 5F Ubiquoss Building, 68 Pangyo-ro 255beon-gil, Bundang-gu Seongnam-si 13486 KR Other 510(k) Applications for this Company
Contact	Sang Keun Lee Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QEB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/16/2022
Decision Date	06/30/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	AN - Anesthesiology
Review Advisory Committee	AN - Anesthesiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review