FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ABBOTT LIFECARE PCA 3 INFUSER, MODEL 12384
K Number: K022203
·
Decision Aug 1, 2002
Classifications
1
FEI Numbers
32
Registration Numbers
32
Same Product Code
30
Applicant Total
883
Review Days
27
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Basic Information
- Device Name
- ABBOTT LIFECARE PCA 3 INFUSER, MODEL 12384
- K Number
- K022203
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 880.5725
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Abbott Laboratories
- Date Received
- July 5, 2002
- Decision Date
- August 1, 2002
- Product Code
- MEA
- 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 |
|---|---|---|---|
| MEA | Pump, Infusion, Pca | FDA class 2 | General Hospital |
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