DISETRONIC PANOMAT PUMP
FDA 510(k) clearance K915566 · decided 1992-08-07
Clearance details
- K-number
- K915566
- Device name
- DISETRONIC PANOMAT PUMP
- Applicant
- Disetronic Medical Systems
- Decision
- Substantially Equivalent
- Date received
- 1991-12-12
- Decision date
- 1992-08-07
- Days to decision
- 239 days
- Clearance type
- Traditional
- Product code
- FRN
- 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 brand 5 ml. glass cartridges used with the Panomat C, Panomat P, Panomat T and recall (Z-1227-04) | Roche Diagnostics Corp. | 2004-07-20 |
| Disetronic brand 5 ml. glass cartridges used with the Panomat C, Panomat P, Panomat T and recall (Z-1228-04) | Roche Diagnostics Corp. | 2004-07-20 |