FDA 510(k) Application Details - K031194

Device Classification Name	Calculator, Predicted Values, Pulmonary Function   More FDA Info for this Device
510(K) Number	K031194
Device Name	Calculator, Predicted Values, Pulmonary Function
Applicant	VIASYS HEALTHCARE GMBH 22705 SAVI RANCH PKWY. YORBA LINDA, CA 92887 US Other 510(k) Applications for this Company
Contact	EARL DRAPER Other 510(k) Applications for this Contact
Regulation Number	868.1890   More FDA Info for this Regulation Number
Classification Product Code	BTY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/16/2003
Decision Date	07/30/2003
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	AN - Anesthesiology
Review Advisory Committee	AN - Anesthesiology
Statement / Summary / Purged Status	Statement
Type	Special
Reviewed By Third Party	N
Expedited Review