HOMEPUMP NSF
FDA 510(k) clearance K932740 · decided 1993-10-06
Clearance details
- K-number
- K932740
- Device name
- HOMEPUMP NSF
- Applicant
- Block Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1993-06-08
- Decision date
- 1993-10-06
- Days to decision
- 120 days
- Clearance type
- Traditional
- Product code
- MED
- Device class
- 2
- Regulation number
- 880.6885
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Carlsbad, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| ON-Q PainBuster with OnDemand (270 ml, 2 ml/hr + 5 ml bolus /60 min refill), Model PMB01, recall (Z-0057-2008) | I-Flow Corporation | 2007-10-06 |
| I-Flow ON-Q PainBuster (100 ml, 2 mI/hr) Pump, PM012, Lot #662449 and 662742 recall (Z-0358-2007) | I-Flow Corporation | 2007-01-18 |
| Easypump ST 100-1 infusion pump recall (Z-0584-06) | I-Flow Corporation | 2006-03-07 |
| Easypump L T 60-24 infusion pump recall (Z-0585-06) | I-Flow Corporation | 2006-03-07 |
| Homepump Eclipse Infusion Pump, Disposable Elastomeric Infusion System (100 ml x 50 ml/hr) recall (Z-0687-03) | I-Flow Corporation | 2003-03-27 |