MODIFICATION TO DISETRONIC D-TRONPLUS INSULIN INFUSION PUMP
FDA 510(k) clearance K022831 · decided 2002-09-11
Clearance details
- K-number
- K022831
- Device name
- MODIFICATION TO DISETRONIC D-TRONPLUS INSULIN INFUSION PUMP
- Applicant
- Disetronic Medical Systems AG
- Decision
- Substantially Equivalent
- Date received
- 2002-08-26
- Decision date
- 2002-09-11
- Days to decision
- 16 days
- Clearance type
- Special
- Product code
- LZG
- Device class
- 2
- Regulation number
- 880.5725
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Burgdorf, SE
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Disetronic D-TRONplus Insulin Pump recall (Z-1198-03) | Roche Diagnostics Corp. | 2003-09-23 |