FDA 510(k) Application Details - K970289

Device Classification Name	Nebulizer (Direct Patient Interface)   More FDA Info for this Device
510(K) Number	K970289
Device Name	Nebulizer (Direct Patient Interface)
Applicant	DEVILBISS HEALTH CARE, INC. 1200 EAST MAIN ST. P.O.BOX 635 SOMERSET, PA 15501-0635 US Other 510(k) Applications for this Company
Contact	FRANK CLEMENTI 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	01/24/1997
Decision Date	04/15/1997
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