FDA 510(k) Application Details - K093862

Device Classification Name	Ventilator, Emergency, Powered (Resuscitator)   More FDA Info for this Device
510(K) Number	K093862
Device Name	Ventilator, Emergency, Powered (Resuscitator)
Applicant	O-TWO MEDICAL TECHNOLOGIES, INC. 7575 KIMBEL ST. MISSISSAUGA, ONTARIO L5S 1C8 CA Other 510(k) Applications for this Company
Contact	David Zhang 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	12/17/2009
Decision Date	05/06/2010
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