FDA 510(k) Application Details - K024344

Device Classification Name	Ventilator, Continuous, Facility Use   More FDA Info for this Device
510(K) Number	K024344
Device Name	Ventilator, Continuous, Facility Use
Applicant	AIRON CORPORATION 102 EAST NEW HAVEN AVE. #146 MELBOURNE, FL 32901 US Other 510(k) Applications for this Company
Contact	G. ERIC GJERDE Other 510(k) Applications for this Contact
Regulation Number	868.5895   More FDA Info for this Regulation Number
Classification Product Code	CBK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/27/2002
Decision Date	06/03/2003
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