FDA 510(k) Application Details - K121747

Device Classification Name	Ventilator, Non-Continuous (Respirator)   More FDA Info for this Device
510(K) Number	K121747
Device Name	Ventilator, Non-Continuous (Respirator)
Applicant	INTERSURGICAL INCORPORATED 417 ELECTRONICS PARKWAY LIVERPOOL, NY 13088 US Other 510(k) Applications for this Company
Contact	MICHAEL ZALEWSKI 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	06/14/2012
Decision Date	03/14/2013
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