MEDFUSION MODEL 4000 SYRINGE INFUSION PUMP, PHARMGUARD TOOLBOX 2 MEDICATION SAFETY SOFTWARE AND SUPPORTED SYRINGES (PSS)
FDA 510(k) clearance K111386 · decided 2011-08-29
Clearance details
- K-number
- K111386
- Device name
- MEDFUSION MODEL 4000 SYRINGE INFUSION PUMP, PHARMGUARD TOOLBOX 2 MEDICATION SAFETY SOFTWARE AND SUPPORTED SYRINGES (PSS)
- Applicant
- Smiths Medical MD, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2011-05-18
- Decision date
- 2011-08-29
- Days to decision
- 103 days
- Clearance type
- Traditional
- Product code
- FRN
- Device class
- 2
- Regulation number
- 880.5725
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- St. Paul, MN, US
- Third-party review
- No
- Expedited review
- No
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