FDA 510(k) Application Details - K080734

Device Classification Name	Calculator, Predicted Values, Pulmonary Function   More FDA Info for this Device
510(K) Number	K080734
Device Name	Calculator, Predicted Values, Pulmonary Function
Applicant	VIASYS HEALTHCARE GMBH LEIBNIZSTRASSE 7 HOECHBERG 97204 DE Other 510(k) Applications for this Company
Contact	THOMAS RUST 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	03/14/2008
Decision Date	06/26/2008
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