FDA 510(k) Application Details - K962848

Device Classification Name	Mask, Oxygen   More FDA Info for this Device
510(K) Number	K962848
Device Name	Mask, Oxygen
Applicant	HANS RUDOLPH, INC. 7200 WYANDOTTE KANSAS CITY, MO 64114 US Other 510(k) Applications for this Company
Contact	KEVIN RUDOLPH Other 510(k) Applications for this Contact
Regulation Number	868.5580   More FDA Info for this Regulation Number
Classification Product Code	BYG Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/22/1996
Decision Date	10/16/1996
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