DAHEDI INSULIN INFUSION PUMP
FDA 510(k) clearance K991376 · decided 1999-06-15
Clearance details
- K-number
- K991376
- Device name
- DAHEDI INSULIN INFUSION PUMP
- Applicant
- Disetronic Medical Systems
- Decision
- Substantially Equivalent
- Date received
- 1999-04-21
- Decision date
- 1999-06-15
- Days to decision
- 55 days
- Clearance type
- Traditional
- Product code
- LZG
- Device class
- 2
- Regulation number
- 880.5725
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Fort Myers, FL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Disetronic Dahedi insulin infusion pump; catalog # 8500019. recall (Z-1244-03) | Roche Diagnostics Corp. | 2003-09-23 |