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510(k) K970989

CYBERREN by Cybernius Medical , Ltd. — Product Code KPF

K970989 is an FDA 510(k) premarket notification submitted by Cybernius Medical , Ltd. for the device "CYBERREN". The FDA issued a decision of Substantially Equivalent on July 24, 1997. 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
July 24, 1997
Date Received
March 18, 1997
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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  • 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)
  • K791676 — PERITONEAL DIALYSIS CYCLER MODEL PDC1000 (December 6, 1979)

FDA data resources