FDA 510(k) Application Details - K030374

Device Classification Name	Nebulizer (Direct Patient Interface)   More FDA Info for this Device
510(K) Number	K030374
Device Name	Nebulizer (Direct Patient Interface)
Applicant	EVIT LABS, INC. 4843 46TH STREET, BUILDING 351 MCCLELLAN, CA 95652 US Other 510(k) Applications for this Company
Contact	S. DAVID PIPER 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	02/04/2003
Decision Date	08/25/2003
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	AN - Anesthesiology
Review Advisory Committee	AN - Anesthesiology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review