FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Kangaroo Connect Enteral Feeding Pump with Kangaroo Connect Feeding Sets, Kangaroo Connect Portal
K Number: K153074
·
Decision Jul 6, 2016
Classifications
1
FEI Numbers
40
Registration Numbers
40
Same Product Code
33
Applicant Total
130
Review Days
258
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Basic Information
- Device Name
- Kangaroo Connect Enteral Feeding Pump with Kangaroo Connect Feeding Sets, Kangaroo Connect Portal
- K Number
- K153074
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5725
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Covidien
- Date Received
- October 22, 2015
- Decision Date
- July 6, 2016
- Product Code
- LZH
- 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 |
|---|---|---|---|
| LZH | Pump, Infusion, Enteral | FDA class 2 | General Hospital |
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