SMARTBLOCK PAIN PUMP
FDA 510(k) clearance K072053 · decided 2007-11-06
Clearance details
- K-number
- K072053
- Device name
- SMARTBLOCK PAIN PUMP
- Applicant
- Medical Flow Systems, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2007-07-26
- Decision date
- 2007-11-06
- Days to decision
- 103 days
- Clearance type
- Traditional
- Product code
- MEB
- Device class
- 2
- Regulation number
- 880.5725
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Leawood, KS, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| SmartBlock PainPump, Part numbers: P49524-S, P49534-S, P49624-S, and P49634-S. recall (Z-1981-2011) | Hsmg, Inc. D/b/a Smartinfuser Usa | 2011-04-14 |
| SmartBlock Pain Management System, Part numbers P49524, P49534, P49624, and P49634. recall (Z-1022-2010) | Hsmg, Inc. D/b/a Smartinfuser Usa | 2010-03-08 |