COLLEAGUE VOLUMETRIC INFUSION PUMP MODEL# 2M8151,8153,8161,8163,9161,9163
FDA 510(k) clearance K063696 · decided 2007-02-27
Clearance details
- K-number
- K063696
- Device name
- COLLEAGUE VOLUMETRIC INFUSION PUMP MODEL# 2M8151,8153,8161,8163,9161,9163
- Applicant
- Baxterhealthcare, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2006-12-13
- Decision date
- 2007-02-27
- Days to decision
- 76 days
- Clearance type
- Traditional
- Product code
- FRN
- Device class
- 2
- Regulation number
- 880.5725
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Deerfield Lake, IL, US
- Third-party review
- No
- Expedited review
- No
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