FDA 510(k) Application Details - K093261

Device Classification Name	Ventilator, Emergency, Powered (Resuscitator)   More FDA Info for this Device
510(K) Number	K093261
Device Name	Ventilator, Emergency, Powered (Resuscitator)
Applicant	THORNHILL RESEARCH INC 70 PETER ST. 2ND FL. TORONTO, ONTARIO M5V 2G5 CA Other 510(k) Applications for this Company
Contact	CLIFF ANSEL Other 510(k) Applications for this Contact
Regulation Number	868.5925   More FDA Info for this Regulation Number
Classification Product Code	BTL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/19/2009
Decision Date	03/26/2010
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	Y