FDA 510(k) Application Details - K001318

Device Classification Name	Attachment, Breathing, Positive End Expiratory Pressure   More FDA Info for this Device
510(K) Number	K001318
Device Name	Attachment, Breathing, Positive End Expiratory Pressure
Applicant	SIMS PORTEX, INC. 10 BOWMAN DR. KEENE, NH 03431 US Other 510(k) Applications for this Company
Contact	BRIAN D FARIAS 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	04/26/2000
Decision Date	07/20/2000
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