FDA 510(k) Application Details - K211589

Device Classification Name	Flowmeter, Blood, Cardiovascular   More FDA Info for this Device
510(K) Number	K211589
Device Name	Flowmeter, Blood, Cardiovascular
Applicant	Remington Medical, Inc. 6830 Meadowridge Court Alpharetta, GA 30005 US Other 510(k) Applications for this Company
Contact	Caitlin Senter Other 510(k) Applications for this Contact
Regulation Number	870.2100   More FDA Info for this Regulation Number
Classification Product Code	DPW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/24/2021
Decision Date	01/27/2022
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review