DISETRONIC H-TRON PLUS V 100 INSULIN INFUSION PUMP
FDA 510(k) clearance K973044 · decided 1997-09-15
Clearance details
- K-number
- K973044
- Device name
- DISETRONIC H-TRON PLUS V 100 INSULIN INFUSION PUMP
- Applicant
- Disetronic Medical Systems
- Decision
- Substantially Equivalent - Subject to Tracking Reg.
- Date received
- 1997-08-15
- Decision date
- 1997-09-15
- Days to decision
- 31 days
- Clearance type
- Traditional
- Product code
- LZG
- Device class
- 2
- Regulation number
- 880.5725
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Minneapolis, MN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Disetronic brand 3.15 ml glass cartridges used with H-tron, H-tron plus, Panomat C, Panoma recall (Z-1222-04) | Roche Diagnostics Corp. | 2004-07-20 |
| Disetronic brand 3.15 ml glass cartridges used with H-tron, H-tron plus, Panomat C, Panoma recall (Z-1223-04) | Roche Diagnostics Corp. | 2004-07-20 |
| Disetronic brand 3.15 ml glass cartridges used with H-tron, H-tron plus, Panomat C, Panoma recall (Z-1224-04) | Roche Diagnostics Corp. | 2004-07-20 |
| Disetronic brand 3.15 ml glass cartridges used with H-tron, H-tron plus, Panomat C, Panoma recall (Z-1225-04) | Roche Diagnostics Corp. | 2004-07-20 |
| Disetronic brand 3.15 ml glass cartridges used with H-tron, H-tron plus, Panomat C, Panoma recall (Z-1226-04) | Roche Diagnostics Corp. | 2004-07-20 |