FDA 510(k) Application Details - K971808

Device Classification Name	Nebulizer (Direct Patient Interface)   More FDA Info for this Device
510(K) Number	K971808
Device Name	Nebulizer (Direct Patient Interface)
Applicant	MONARCH MEDICAL 4550 BIRCH BAY/LYNDEN RD. SUITE B138 BLAINE, WA 98230 US Other 510(k) Applications for this Company
Contact	MO SHARIFF 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	05/15/1997
Decision Date	09/26/1997
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