FDA 510(k) Application Details - K973419

Device Classification Name	Ventilator, Emergency, Manual (Resuscitator)   More FDA Info for this Device
510(K) Number	K973419
Device Name	Ventilator, Emergency, Manual (Resuscitator)
Applicant	NELLCOR PURITAN BENNETT, INC. 4280 HACIENDA DR. PLEASANTON, CA 94588-2719 US Other 510(k) Applications for this Company
Contact	SHERYLL A MATHEWS Other 510(k) Applications for this Contact
Regulation Number	868.5915   More FDA Info for this Regulation Number
Classification Product Code	BTM Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/10/1997
Decision Date	03/25/1998
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