510(k) K955010

AUTOVAC BP SYSTE, 2000 SERIES by Boehringer Laboratories — Product Code CAC

K955010 is an FDA 510(k) premarket notification submitted by Boehringer Laboratories for the device "AUTOVAC BP SYSTE, 2000 SERIES". The FDA issued a decision of Substantially Equivalent on June 20, 1996. The device falls under product code CAC (Apparatus, Autotransfusion), a Class II device regulated under 21 CFR 868.5830. Boehringer Laboratories has at least 10 other 510(k) clearances on record.