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510(k) K023471

DISETRONIC H-TRONPLUS INSULIN INFUSION PUMP by Disetronic Medical Systems AG — Product Code LZG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 29, 2002
Date Received
October 15, 2002
Clearance Type
Special
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)
  • K060876 — ACCU-CHEK INSULIN PUMP CONFIGURATION SOFTWARE (STANDARD), MODEL 04625137001; ACC (June 15, 2006)
  • K042887 — ACCU-CHEK SPIRIT (March 18, 2005)
  • K043000 — MODIFICATION TO D-TRONPLUS (December 1, 2004)
  • K033892 — ULTRAFLEX INFUSION SET (March 9, 2004)
  • 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)

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  • K180045 — Omnipod DASH Insulin Management System (June 1, 2018)
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  • K162080 — t:slim Insulin Delivery System, t:flex Insulin Delivery System, Tandem Device Up (October 25, 2016)