ACCU-CHEK INSULIN PUMP CONFIGURATION SOFTWARE (STANDARD), MODEL 04625137001; ACCU-CHEK INSULIN PUMP CONFIGURATION SOFTWA
FDA 510(k) clearance K060876 · decided 2006-06-15
Clearance details
- K-number
- K060876
- Device name
- ACCU-CHEK INSULIN PUMP CONFIGURATION SOFTWARE (STANDARD), MODEL 04625137001; ACCU-CHEK INSULIN PUMP CONFIGURATION SOFTWA
- Applicant
- Disetronic Medical Systems AG
- Decision
- Substantially Equivalent
- Date received
- 2006-03-31
- Decision date
- 2006-06-15
- Days to decision
- 76 days
- Clearance type
- Traditional
- Product code
- LZG
- Device class
- 2
- Regulation number
- 880.5725
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Indianapolis, IN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Roche ACCU-CHEK Spirit insulin pump. Part numbers 4540492001, 4759702001 and 4759729001. recall (Z-1646-2009) | Disetronic Medical Systems, Inc. | 2009-05-26 |