FDA 510(k) Application Details - K210862

Device Classification Name	Apparatus, Autotransfusion   More FDA Info for this Device
510(K) Number	K210862
Device Name	Apparatus, Autotransfusion
Applicant	Sisu Global Health 2720 Sisson Street Baltimore, MD 21211 US Other 510(k) Applications for this Company
Contact	Gillian Henker 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	03/23/2021
Decision Date	07/29/2021
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	AN - Anesthesiology
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review