FDA 510(k) Application Details - K983920

Device Classification Name	Attachment, Breathing, Positive End Expiratory Pressure   More FDA Info for this Device
510(K) Number	K983920
Device Name	Attachment, Breathing, Positive End Expiratory Pressure
Applicant	ENGINEERED MEDICAL SYSTEMS 8529 ZIONSVILLE RD. P.O. BOX 681514 INDIANAPOLIS, IN 46268 US Other 510(k) Applications for this Company
Contact	JEFF QUINN Other 510(k) Applications for this Contact
Regulation Number	868.5965   More FDA Info for this Regulation Number
Classification Product Code	BYE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/04/1998
Decision Date	01/22/1999
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