FDA 510(k) Application Details - K130481

Device Classification Name	Ventilator, Non-Continuous (Respirator)   More FDA Info for this Device
510(K) Number	K130481
Device Name	Ventilator, Non-Continuous (Respirator)
Applicant	CIRCADIANCE LLC 3919 WILLIAM PENN HWY. SUITE 200 MURRYSVILLE, PA 15668 US Other 510(k) Applications for this Company
Contact	RYAN T KASUN Other 510(k) Applications for this Contact
Regulation Number	868.5905   More FDA Info for this Regulation Number
Classification Product Code	BZD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/25/2013
Decision Date	05/24/2013
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