FDA 510(k) Application Details - K053490

Device Classification Name	Nebulizer (Direct Patient Interface)   More FDA Info for this Device
510(K) Number	K053490
Device Name	Nebulizer (Direct Patient Interface)
Applicant	MERITS HEALTH PRODUCTS CO., LTD. 9, ROAD 36 TAICHUNG INDUSTRIAL PARK TAICHUNG 407 TW Other 510(k) Applications for this Company
Contact	STEVE CHAO 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	12/15/2005
Decision Date	07/24/2006
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	AN - Anesthesiology
Review Advisory Committee	AN - Anesthesiology
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review