FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
NIPRO PUREFLUX-L HEMODIALYZER
K Number: K122952
·
Decision Dec 4, 2013
Classifications
1
FEI Numbers
8
Registration Numbers
8
Same Product Code
130
Applicant Total
34
Review Days
435
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Basic Information
- Device Name
- NIPRO PUREFLUX-L HEMODIALYZER
- K Number
- K122952
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5820
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Nipro Medical Corporation
- Date Received
- September 25, 2012
- Decision Date
- December 4, 2013
- Product Code
- FJI
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- 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 |
|---|---|---|---|
| FJI | Dialyzer, Capillary, Hollow Fiber | FDA class 2 | Gastroenterology, Urology |
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