Home / 510(k) Clearances / K060876

510(k) K060876

ACCU-CHEK INSULIN PUMP CONFIGURATION SOFTWARE (STANDARD), MODEL 04625137001; ACCU-CHEK INSULIN PUMP CONFIGURATION SOFTWA by Disetronic Medical Systems AG — Product Code LZG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 15, 2006
Date Received
March 31, 2006
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pump, Infusion, Insulin
Device Class
Class II
Regulation Number
880.5725
Review Panel
CH
Submission Type

Other clearances by Disetronic Medical Systems AG

  • K100704 — ACCU-CHEK FLEXLINK PLUS INFUSION SET, ACCU-CHECK LINKASSIST PLUS INSERTION DEVIC (May 14, 2010)
  • K070189 — ACCU-CHEK ULTRAFLEX INFUSION SET (February 21, 2007)
  • K063146 — ACCU-CHEK LINKASSIST (November 27, 2006)
  • K042887 — ACCU-CHEK SPIRIT (March 18, 2005)
  • K043000 — MODIFICATION TO D-TRONPLUS (December 1, 2004)
  • K033892 — ULTRAFLEX INFUSION SET (March 9, 2004)
  • K023471 — DISETRONIC H-TRONPLUS INSULIN INFUSION PUMP (October 29, 2002)
  • K022831 — MODIFICATION TO DISETRONIC D-TRONPLUS INSULIN INFUSION PUMP (September 11, 2002)
  • K021725 — DISETRONIC D-TRON INSULIN INFUSION PUMP (August 2, 2002)
  • K013782 — DISETRONIC PENFINE INSULIN INJECTION PEN NEEDLE (November 20, 2001)

Other clearances for product code LZG

  • K240158 — Modular Medical MODD1 Insulin Delivery System (September 4, 2024)
  • K241622 — Extended Reservoir; MiniMed Reservoir (July 2, 2024)
  • K223372 — Omnipod GO Insulin Delivery Device (April 24, 2023)
  • K210714 — Extended Reservoir (April 6, 2022)
  • K211575 — Omnipod® Insulin Management System, Omnipod DASH® Insulin Management System (August 13, 2021)
  • K192659 — Omnipod Insulin Management System, Omnipod DASH Insulin Management System (October 21, 2019)
  • K182630 — Omnipod Insulin Management System, Omnipod DASH Insulin Management System (January 8, 2019)
  • K180045 — Omnipod DASH Insulin Management System (June 1, 2018)
  • K162296 — OmniPod Insulin Management System (April 18, 2017)
  • K162080 — t:slim Insulin Delivery System, t:flex Insulin Delivery System, Tandem Device Up (October 25, 2016)