FDA 510(k) Application Details - K180831

Device Classification Name	Apparatus, Autotransfusion   More FDA Info for this Device
510(K) Number	K180831
Device Name	Apparatus, Autotransfusion
Applicant	Fresenius Kabi AG Else-Kroner-Strasse 1 Bad Homburg 61352 DE Other 510(k) Applications for this Company
Contact	Barry G. Hicks Other 510(k) Applications for this Contact
Regulation Number	868.5830   More FDA Info for this Regulation Number
Classification Product Code	CAC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/30/2018
Decision Date	12/10/2018
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	AN - Anesthesiology
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review