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510(k) K821328

C.A.P.D. AUTOMATIC HEATER #PDC 2000 HCP by Medionics International , Ltd. — Product Code KPF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 28, 1982
Date Received
May 4, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Dialysate Delivery, Semi-Automatic, Peritoneal
Device Class
Class II
Regulation Number
876.5630
Review Panel
GU
Submission Type

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Other clearances for product code KPF

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  • K970989 — CYBERREN (July 24, 1997)
  • K955762 — PACKPD PERITONEAL DIALYSIS UREA KINETIC MODELING SOFTWARE PROGRAM (July 31, 1996)
  • K913515 — TOTAL CONTAINMENT DEVICE (May 26, 1994)
  • K875121 — AMICON EQUALINE FLUID BALANCE SYSTEM (February 19, 1988)
  • K874020 — ULTRACARE(TM) AUTOMATED PATIENT ASSIST DEVICE (January 29, 1988)
  • K802831 — GAMBRO PERITONEAL DIALYSIS MONITOR (December 18, 1980)
  • K800496 — CYCLER W/5 OR 10 HR. FILL/DWELL TIMER (July 21, 1980)
  • K791676 — PERITONEAL DIALYSIS CYCLER MODEL PDC1000 (December 6, 1979)