FLEXIFLO QUANTUM ENTERAL PUMP
FDA 510(k) clearance K944669 · decided 1995-07-24
Clearance details
- K-number
- K944669
- Device name
- FLEXIFLO QUANTUM ENTERAL PUMP
- Applicant
- Abbott Mfg., Inc.
- Decision
- Substantially Equivalent
- Date received
- 1994-09-13
- Decision date
- 1995-07-24
- Days to decision
- 314 days
- Clearance type
- Traditional
- Product code
- FRN
- Device class
- 2
- Regulation number
- 880.5725
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Columbus, OH, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Flexiflo Quantum Enteral Pump, List number 50596, AC cord manufactured by Electri-Cord, We recall (Z-0013-2010) | Hospira Inc | 2009-10-06 |
| Fleixiflo Quantum Enteral Pump. recall (Z-0145-06) | Abbott Laboratories | 2005-11-16 |
| Flexiflo Quantum Enteral Pump recall (Z-0570-05) | Ross Products Division Abbott Laboratories | 2005-03-08 |