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510(k) K790824

REPGREEN ULTRAFILTRATION MONITOR by Cyberex Corp. — Product Code FIL

K790824 is an FDA 510(k) premarket notification submitted by Cyberex Corp. for the device "REPGREEN ULTRAFILTRATION MONITOR". The FDA issued a decision of Substantially Equivalent on June 27, 1979. The device falls under product code FIL (System, Dialysate Delivery, Single Pass), a Class II device regulated under 21 CFR 876.5820. Cyberex Corp. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 27, 1979
Date Received
May 1, 1979
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Dialysate Delivery, Single Pass
Device Class
Class II
Regulation Number
876.5820
Review Panel
GU
Submission Type

Other clearances by Cyberex Corp.

  • K810837 — CYBER 80 HEMODIALYZER (May 5, 1981)
  • K802478 — CYBER 120 HEMODIALYZER (March 20, 1981)
  • K801377 — CYBER 120 HEMODIALYZER (August 27, 1980)

Other clearances for product code FIL

  • K011741 — CRIT-LINE MONITOR III TQA (CLM TQA) (July 23, 2002)
  • K901038 — SPS 550-IPS (INTEGRATED PATIENT STATION) (April 19, 1990)
  • K890329 — FRESENIUS 2008 BSS BEDSIDE DIALYSIS SYSTEM (May 11, 1989)
  • K781633 — ULTRAFILTRATION SCALE (December 7, 1978)
  • K771875 — ULTRAFILTRATION MONITOR 5M9034 (November 30, 1977)
  • K771227 — AK-10 (August 2, 1977)
  • K770137 — NEGATIVE PRESSURE ADAPTER 5M1350 (February 1, 1977)

FDA data resources