FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BECTON DICKINSON INTELLIPORT SYSTEM
K Number: K141474
·
Decision Dec 18, 2014
Classifications
1
FEI Numbers
26
Registration Numbers
26
Same Product Code
9
Applicant Total
190
Review Days
198
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Basic Information
- Device Name
- BECTON DICKINSON INTELLIPORT SYSTEM
- K Number
- K141474
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5725
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Becton, Dickinson & CO
- Date Received
- June 3, 2014
- Decision Date
- December 18, 2014
- Product Code
- PHC
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| PHC | Infusion Safety Management Software | FDA class 2 | General Hospital |
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