FDA 510(k) Application Details - K052438

Device Classification Name	Nebulizer (Direct Patient Interface)   More FDA Info for this Device
510(K) Number	K052438
Device Name	Nebulizer (Direct Patient Interface)
Applicant	EMG TECHNOLOGY CO., LTD. 98 STANTON STREET WILKES BARRE, PA 18702 US Other 510(k) Applications for this Company
Contact	GENE R KULON 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	09/06/2005
Decision Date	01/31/2006
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	AN - Anesthesiology
Review Advisory Committee	AN - Anesthesiology
Statement / Summary / Purged Status	Statement
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review