ACCUFLOW AND ACCUFLUX ELASTOMERIC INFUSION PUMP
FDA 510(k) clearance K081905 · decided 2008-07-15
Clearance details
- K-number
- K081905
- Device name
- ACCUFLOW AND ACCUFLUX ELASTOMERIC INFUSION PUMP
- Applicant
- Westmed, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2008-07-03
- Decision date
- 2008-07-15
- Days to decision
- 12 days
- Clearance type
- Traditional
- Product code
- MEB
- Device class
- 2
- Regulation number
- 880.5725
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Highlands Ranch, CO, US
- Third-party review
- Yes
- Expedited review
- No
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