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510(k) K770263

DIALYSATE METER RS-2100A, CIRCUIT CHANGE by Renal Systems, Inc. — Product Code FLB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 18, 1977
Date Received
February 11, 1977
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

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  • K840182 — RENAPAK CONCENTRATE MIXING SYS. (May 2, 1984)
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  • K821415 — MODEL 90 BC (May 27, 1982)