FDA 510(k) Application Details - K100121

Device Classification Name	Ventilator, Non-Continuous (Respirator)   More FDA Info for this Device
510(K) Number	K100121
Device Name	Ventilator, Non-Continuous (Respirator)
Applicant	AEIOMED, INC. 1313 5TH STREET SE, STE 205 MINNEAPOLIS, MN 55414 US Other 510(k) Applications for this Company
Contact	DARIN BUSCH 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	01/15/2010
Decision Date	07/13/2010
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	AN - Anesthesiology
Review Advisory Committee	AN - Anesthesiology
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review