Disetronic H-Tronplus Insulin Infusion Pump
FDA 510(k) K023471 · Disetronic Medical Systems AG
510(k) numberK023471
Submission
- Device name
- Disetronic H-Tronplus Insulin Infusion Pump
- Applicant
- Disetronic Medical Systems AG
St. Paul, MN, US - Received
- October 15, 2002
- Decision date
- October 29, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LZG – Pump, Infusion, Insulin
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5725
- Specialty
- General Hospital
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More from Insulet Corporation
| 510(k) | Device | Decision |
|---|---|---|
| K100704 | Accu-Chek Flexlink Plus Infusion Set, Accu-Check Linkassist Plus Insertion DeviceFRN · Special | 05/14/2010SE |
| K070189 | Accu-Chek Ultraflex Infusion SetFPA · Special | 02/21/2007SE |
| K063146 | Accu-Chek LinkassistKZH · Traditional | 11/27/2006SE |
| K060876 | Accu-Chek Insulin Pump Configuration Software (Standard), Model 04625137001; Accu-Chek…LZG · Traditional | 06/15/2006SE |
| K042887 | Accu-Chek SpiritLZG · Traditional | 03/18/2005SE |
| K043000 | Modification to D-TronplusLZG · Special | 12/01/2004SE |
| K033892 | Ultraflex Infusion SetFPA · Traditional | 03/09/2004SE |
| K022831 | Modification to Disetronic D-Tronplus Insulin Infusion PumpLZG · Special | 09/11/2002SE |
| K021725 | Disetronic D-Tron Insulin Infusion PumpLZG · Special | 08/02/2002SE |
| K013782 | Disetronic Penfine Insulin Injection Pen NeedleFMI · Traditional | 11/20/2001SE |
Questions and answers
When was Disetronic H-Tronplus Insulin Infusion Pump cleared by the FDA?
Disetronic H-Tronplus Insulin Infusion Pump (K023471) received a 510(k) decision of Substantially Equivalent on October 29, 2002, 14 days after the submission was received.
What is the product code of K023471?
The FDA product code is LZG – Pump, Infusion, Insulin, a Class II (moderate risk) device regulated under 21 CFR 880.5725.