510(k) K953551

KNOW-RECIRC by H&H Control Systems — Product Code MQS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 21, 1996
Date Received
July 28, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Hemodialysis, Access Recirculation Monitoring
Device Class
Class II
Regulation Number
876.5820
Review Panel
GU
Submission Type