FDA 510(k) Application Details - K070210

Device Classification Name	Ventilator, Emergency, Powered (Resuscitator)   More FDA Info for this Device
510(K) Number	K070210
Device Name	Ventilator, Emergency, Powered (Resuscitator)
Applicant	OHMEDA MEDICAL 8880 GORMAN RD. LAUREL, MD 20723 US Other 510(k) Applications for this Company
Contact	AGATA SMIEJA 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	01/22/2007
Decision Date	04/20/2007
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