SANDOZ NUTRITION COMPAT(R) ENTERAL FEEDING PUMP
FDA 510(k) clearance K940556 · decided 1994-11-07
Clearance details
- K-number
- K940556
- Device name
- SANDOZ NUTRITION COMPAT(R) ENTERAL FEEDING PUMP
- Applicant
- Sandoz Nutrition
- Decision
- Substantially Equivalent
- Date received
- 1994-02-07
- Decision date
- 1994-11-07
- Days to decision
- 273 days
- Clearance type
- Traditional
- Product code
- LZH
- 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 |
|---|---|---|
| Compat Enteral Delivery Pump Set with Piercing Spike, Item number 19930700 recall (Z-0607-03) | Novartis Nutrition Corp | 2003-03-05 |
| Compat 500 mL Baggle Top Fill Enteral Feeding Container with Preattached Enteral Delivery recall (Z-0608-03) | Novartis Nutrition Corp | 2003-03-05 |