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510(k) K883490

ACCUFLO UF CONTROL MODULE NO. 74-0100-3 by National Medical Care, Medical Products Div., Inc. — Product Code FJB

K883490 is an FDA 510(k) premarket notification submitted by National Medical Care, Medical Products Div., Inc. for the device "ACCUFLO UF CONTROL MODULE NO. 74-0100-3". The FDA issued a decision of Substantially Equivalent on September 29, 1988. The device falls under product code FJB (Detector, Dialysate Level), a Class II device regulated under 21 CFR 876.5820. National Medical Care, Medical Products Div., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 29, 1988
Date Received
August 16, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Detector, Dialysate Level
Device Class
Class II
Regulation Number
876.5820
Review Panel
GU
Submission Type

Other clearances by National Medical Care, Medical Products Div., Inc.

  • K962081 — COMBILINES HEMODIALYSIS BLOOD TUBING SET (November 1, 1996)
  • K941757 — FORMALIN REUSE CART (January 22, 1996)
  • K952343 — FOCUA 90R, 90HR, 120R, 120HR, 160R, 160HR HOLLOW FIBER DIALYZER (December 22, 1995)
  • K930843 — RAPID DISCONNECT Y-SET, CAT. NO. 48-7000 (August 31, 1994)
  • K914790 — HOLLOW FIBER DIALYZER FOCUS 9OR/90H-R/120R/120H-R (March 5, 1993)
  • K920693 — DEXTROLYTE II PERITONEAL DIALYSIS 48-3028-9 (September 21, 1992)
  • K920697 — DEXTROLYTE II PERITONEAL DIALYSIS 48-3029-7 CLAMP (September 21, 1992)
  • K920586 — DEXTROLYTE II PERITONEAL DIALYSIS ADMIN. SET (September 21, 1992)
  • K920797 — HEMODIALYSIS BLOOD TUBING SET (September 21, 1992)
  • K920029 — DEXTROLYTE II CAPD TRNSFER SET (September 21, 1992)

Other clearances for product code FJB

  • K881062 — CENTRY 2 ULTRAFILTRATION CONTROL KIT, #018762-002 (April 21, 1988)
  • K875312 — UFR DIGITAL RETROFIT (February 19, 1988)

FDA data resources