FDA 510(k) Application Details - K112546

Device Classification Name	Attachment, Breathing, Positive End Expiratory Pressure   More FDA Info for this Device
510(K) Number	K112546
Device Name	Attachment, Breathing, Positive End Expiratory Pressure
Applicant	O-TWO MEDICAL TECHNOLOGIES, INC. 7575 KIMBEL ST. MISSISSAUGA, ONTARIO L5S 1C8 CA Other 510(k) Applications for this Company
Contact	AMMAR AL-DOJAILY 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	09/01/2011
Decision Date	12/27/2011
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