FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇪 Germany
Accu-Chek FlexLink Plus infusion set
K Number: K143446
·
Decision Aug 13, 2015
Classifications
1
FEI Numbers
424
Registration Numbers
424
Same Product Code
1173
Applicant Total
5
Review Days
254
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Basic Information
- Device Name
- Accu-Chek FlexLink Plus infusion set
- K Number
- K143446
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5440
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Roche Diagnostics GmbH
- Date Received
- December 2, 2014
- Decision Date
- August 13, 2015
- Product Code
- FPA
- 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 |
|---|---|---|---|
| FPA | Set, Administration, Intravascular | FDA class 2 | General Hospital |
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