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510(k) K801377

CYBER 120 HEMODIALYZER by Cyberex Corp. — Product Code FJG

K801377 is an FDA 510(k) premarket notification submitted by Cyberex Corp. for the device "CYBER 120 HEMODIALYZER". The FDA issued a decision of Substantially Equivalent on Aug 27, 1980. The device falls under product code FJG (Dialyzer, Parallel Flow), a Class II device regulated under 21 CFR 876.5820. Cyberex Corp. has 3 other 510(k) clearances on record.

Clearance details

Decision
SESE (Substantially Equivalent)
Decision Date
Aug 27, 1980
Date Received
Jun 11, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device classification

Device Name
Dialyzer, Parallel Flow
Device Class
Class II
Regulation Number
876.5820
Review Panel
GU
Submission Type
510(k)

Other clearances by Cyberex Corp.

  • K810837 — CYBER 80 HEMODIALYZER (May 5, 1981)
  • K802478 — CYBER 120 HEMODIALYZER (Mar 20, 1981)
  • K790824 — REPGREEN ULTRAFILTRATION MONITOR (Jun 27, 1979)

Other clearances for product code FJG

  • K933681 — GAMBRO LUNDIA PRO 100, 500, 600 DIALYZERS (Sep 7, 1994)
  • K933680 — GAMBRO LUNDIA PRO 200 DIALYZER (Aug 26, 1994)
  • K920693 — DEXTROLYTE II PERITONEAL DIALYSIS 48-3028-9 (Sep 21, 1992)
  • K915504 — GAMBRO LUNDIA ALPHA HEMODIALYZERS (Mar 6, 1992)
  • K901368 — HEMOSPAL KITS A1, A2D, AO, & A1D (Aug 2, 1990)
  • K902203 — TENCKHOFF PERITONEAL DIALYSIS KIT (Aug 1, 1990)
  • K862840 — GAMBRO LUNDIA 10-1L, 1N, 1H, 3H, 4N, 4H, 5H, 6N (Sep 29, 1986)
  • K853406 — GAMBRO LUNDIA PRO 3 & 5 DIALYZER (Jan 8, 1986)
  • K820694 — COBE PPD 1.3L, #18-520-009 (Mar 31, 1982)
  • K812336 — COBE PPD 1.9 (Aug 31, 1981)

FDA data resources

Source: FDA 510(k) database entry for K801377. Report a data issue: hello@regdatalab.com.