SMARTINFUSER PAINPUMP, MODEL P49220 W/CATHETER SET; P49224N W/O CATHETER SET
FDA 510(k) clearance K061409 · decided 2006-06-16
Clearance details
- K-number
- K061409
- Device name
- SMARTINFUSER PAINPUMP, MODEL P49220 W/CATHETER SET; P49224N W/O CATHETER SET
- Applicant
- Precise Medical Products, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2006-05-22
- Decision date
- 2006-06-16
- Days to decision
- 25 days
- Clearance type
- Special
- Product code
- MEB
- Device class
- 2
- Regulation number
- 880.5725
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Shlomi, IL
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| SmartInfuser PainPump, Part numbers: P49220-S, P49230-S, P49230-SD, P49234-S, and P49234-S recall (Z-1982-2011) | Hsmg, Inc. D/b/a Smartinfuser Usa | 2011-04-14 |
| SmartInfuser PainPump, part numbers P49230, P49220, P49224-D, P49224N, P49230-D and P49234 recall (Z-1021-2010) | Hsmg, Inc. D/b/a Smartinfuser Usa | 2010-03-08 |