FDA 510(k) Application Details - K960854

Device Classification Name	Nebulizer (Direct Patient Interface)   More FDA Info for this Device
510(K) Number	K960854
Device Name	Nebulizer (Direct Patient Interface)
Applicant	PACESETTER, INC. 49 PLAIN ST. NORTH ATTLEBORO, MA 02760-3577 US Other 510(k) Applications for this Company
Contact	STEVEN CLARKE 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	03/01/1996
Decision Date	12/23/1996
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