FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BD Intelliport System; BD Intelliport Reader (516230); BD Intelliport Sensor (516229); BD Intelliport Gateway (516232); BD Intelliport Mount (516233); BD Intelliport Charger (516231)
K Number: K243062
·
Decision Jun 20, 2025
Classifications
1
FEI Numbers
26
Registration Numbers
26
Same Product Code
9
Applicant Total
6
Review Days
266
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Basic Information
- Device Name
- BD Intelliport System; BD Intelliport Reader (516230); BD Intelliport Sensor (516229); BD Intelliport Gateway (516232); BD Intelliport Mount (516233); BD Intelliport Charger (516231)
- K Number
- K243062
- 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
- Date Received
- September 27, 2024
- Decision Date
- June 20, 2025
- 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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