FDA 510(k) Application Details - K080256

Device Classification Name	Attachment, Breathing, Positive End Expiratory Pressure   More FDA Info for this Device
510(K) Number	K080256
Device Name	Attachment, Breathing, Positive End Expiratory Pressure
Applicant	PULMODYNE 24301 WOODSAGE DRIVE BONITA SPRINGS, FL 33134-2958 US Other 510(k) Applications for this Company
Contact	PAUL DRYDEN 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	01/31/2008
Decision Date	05/09/2008
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