FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Volumetric Infusion Controller
K Number: K153760
·
Decision Oct 3, 2016
Classifications
1
FEI Numbers
6
Registration Numbers
6
Same Product Code
59
Applicant Total
3
Review Days
278
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Basic Information
- Device Name
- Volumetric Infusion Controller
- K Number
- K153760
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5725
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- DEKA Research & Development
- Date Received
- December 30, 2015
- Decision Date
- October 3, 2016
- Product Code
- LDR
- 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 |
|---|---|---|---|
| LDR | Controller, Infusion, Intravascular, Electronic | FDA class 2 | General Hospital |
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