FDA 510(k) Application Details - K192368

Device Classification Name	Apparatus, Autotransfusion   More FDA Info for this Device
510(K) Number	K192368
Device Name	Apparatus, Autotransfusion
Applicant	Fresenius Kabi AG Else-Kroner-Strasse 1 Bad Homburg 61352 DE Other 510(k) Applications for this Company
Contact	Shane Sawall 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	08/30/2019
Decision Date	09/27/2019
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	AN - Anesthesiology
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review