FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇪 Germany
COMPAT GO ENTERAL FEEDING PUMP AND ADMINISTRATION SETS
K Number: K060316
·
Decision Jun 23, 2006
Classifications
1
FEI Numbers
40
Registration Numbers
40
Same Product Code
33
Applicant Total
1
Review Days
135
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Basic Information
- Device Name
- COMPAT GO ENTERAL FEEDING PUMP AND ADMINISTRATION SETS
- K Number
- K060316
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5725
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Fresenius Kabi Deutschland GmbH
- Date Received
- February 8, 2006
- Decision Date
- June 23, 2006
- Product Code
- LZH
- 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 |
|---|---|---|---|
| LZH | Pump, Infusion, Enteral | FDA class 2 | General Hospital |
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