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510(k) K791676

PERITONEAL DIALYSIS CYCLER MODEL PDC1000 by J.M. Sounds Electronics Co. — Product Code KPF

K791676 is an FDA 510(k) premarket notification submitted by J.M. Sounds Electronics Co. for the device "PERITONEAL DIALYSIS CYCLER MODEL PDC1000". The FDA issued a decision of Substantially Equivalent on December 6, 1979. The device falls under product code KPF (System, Dialysate Delivery, Semi-Automatic, Peritoneal), a Class II device regulated under 21 CFR 876.5630.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 6, 1979
Date Received
August 27, 1979
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

Other clearances for product code KPF

  • K061515 — RENALSOFT (September 11, 2006)
  • K990953 — RENAL LINK (June 18, 1999)
  • 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)
  • K821328 — C.A.P.D. AUTOMATIC HEATER #PDC 2000 HCP (July 28, 1982)
  • K802831 — GAMBRO PERITONEAL DIALYSIS MONITOR (December 18, 1980)
  • K800496 — CYCLER W/5 OR 10 HR. FILL/DWELL TIMER (July 21, 1980)

FDA data resources