FDA 510(k) Application Details - K121969

Device Classification Name	Nebulizer (Direct Patient Interface)   More FDA Info for this Device
510(K) Number	K121969
Device Name	Nebulizer (Direct Patient Interface)
Applicant	TaiDoc Technology Corporation 3F,5F, No.127, Wugong 2nd Rd. Wugu District New Taipei City 24888 TW Other 510(k) Applications for this Company
Contact	PINJUNG CHEN 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	07/05/2012
Decision Date	02/28/2013
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