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510(k) K032075

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

K032075 is an FDA 510(k) premarket notification submitted by Ibp Instruments GmbH for the device "CONDUCTIVITY STANDARD SOLUTION-METERCARE". The FDA issued a decision of Substantially Equivalent on September 17, 2003. The device falls under product code FKH (Solution-Test Standard-Conductivity, Dialysis), a Class II device regulated under 21 CFR 876.5820. Ibp Instruments GmbH has at least 2 other 510(k) clearances on record.

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

Other clearances for product code FKH

  • K191496 — TDS Standard Solution (August 5, 2019)
  • K130100 — COMINED STANDARD SOLUTION (April 18, 2013)
  • K041636 — H&S-CONDUCTIVITY STANDARD SOLUTION (July 2, 2004)
  • 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)

FDA data resources