FDA 510(k)
FDA class 2
Substantially Equivalent
🇪🇸 Spain
DOSI-FUSER
K Number: K040752
·
Decision Apr 7, 2004
Classifications
1
FEI Numbers
24
Registration Numbers
24
Same Product Code
87
Applicant Total
5
Review Days
14
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Basic Information
- Device Name
- DOSI-FUSER
- K Number
- K040752
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5725
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Leventon, S.A.
- Date Received
- March 24, 2004
- Decision Date
- April 7, 2004
- Product Code
- MEB
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- Third Party
- Y
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| MEB | Pump, Infusion, Elastomeric | FDA class 2 | General Hospital |
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