SMARTINFUSER PAINPUMP
FDA 510(k) clearance K042122 · decided 2004-09-22
Clearance details
- K-number
- K042122
- Device name
- SMARTINFUSER PAINPUMP
- Applicant
- Precise Medical Products
- Decision
- Substantially Equivalent
- Date received
- 2004-08-06
- Decision date
- 2004-09-22
- Days to decision
- 47 days
- Clearance type
- Traditional
- 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 |