FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BARD PCA II INFUSION PUMP
K Number: K880733
·
Decision Jun 20, 1988
Classifications
1
FEI Numbers
159
Registration Numbers
159
Same Product Code
844
Applicant Total
566
Review Days
117
Basic Information
- Device Name
- BARD PCA II INFUSION PUMP
- K Number
- K880733
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5725
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- C.R. BARD, INC.
- Date Received
- February 24, 1988
- Decision Date
- June 20, 1988
- Product Code
- FRN
- 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 |
|---|---|---|---|
| FRN | Pump, Infusion | FDA class 2 | General Hospital |
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