FDA 510(k) Application Details - K180871

Device Classification Name	Nebulizer (Direct Patient Interface)   More FDA Info for this Device
510(K) Number	K180871
Device Name	Nebulizer (Direct Patient Interface)
Applicant	MicroBase Technology Corporation No. 756, Jiadong Road Bade District, Taoyuan City 33464 TW Other 510(k) Applications for this Company
Contact	Molly Hsieh Other 510(k) Applications for this Contact
Regulation Number	868.5630   More FDA Info for this Regulation Number
Classification Product Code	CAF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/03/2018
Decision Date	09/14/2018
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