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510(k) K032075

CONDUCTIVITY STANDARD SOLUTION-METERCARE by Ibp Instruments GmbH — Product Code FKH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 17, 2003
Date Received
July 7, 2003
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Solution-Test Standard-Conductivity, Dialysis
Device Class
Class II
Regulation Number
876.5820
Review Panel
GU
Submission Type

Other clearances by Ibp Instruments GmbH

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  • K033330 — CONDUCTIVITY/TDS CALIBRATOR SOLUTION (February 27, 2004)
  • K863824 — SOLUTION/TEST STANDARD/CONDUCT. DIALY.&MULT.SOLUT. (October 24, 1986)
  • K851362 — STANDARD SOLUTION OF CONDUCTIVITY & MEASUREMENT OF (June 12, 1985)
  • K812622 — HEMODIALYSIS VENOUS & ARTERIAL SET (September 24, 1981)