FDA 510(k) Application Details - K071221

Device Classification Name	Ventilator, Emergency, Powered (Resuscitator)   More FDA Info for this Device
510(K) Number	K071221
Device Name	Ventilator, Emergency, Powered (Resuscitator)
Applicant	AUTOMEDX INC. 12321 MIDDLEBROOK RD SUITE 150 GERMANTOWN, MD 20874 US Other 510(k) Applications for this Company
Contact	JAMES D EVANS 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	05/02/2007
Decision Date	09/06/2007
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