FDA 510(k) Application Details - K113549

Device Classification Name	Device, Positive Pressure Breathing, Intermittent   More FDA Info for this Device
510(K) Number	K113549
Device Name	Device, Positive Pressure Breathing, Intermittent
Applicant	SEOIL PACIFIC CORP. RM # 515-516, ACE HIGH-END TOWER 235-2 GURO-DONG SEOUL 573-901 KR Other 510(k) Applications for this Company
Contact	Priscilla Chung Other 510(k) Applications for this Contact
Regulation Number	868.5905   More FDA Info for this Regulation Number
Classification Product Code	NHJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/01/2011
Decision Date	02/21/2013
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