510(k) K955298

PHOENIX DIALYSATE METER by Automata Medical Instrumentation, Inc. — Product Code FIZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 29, 1996
Date Received
November 20, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Meter, Conductivity, Non-Remote
Device Class
Class II
Regulation Number
876.5820
Review Panel
GU
Submission Type