FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
RENAFLO II
K Number: K823546
·
Decision Dec 16, 1982
Classifications
1
FEI Numbers
39
Registration Numbers
39
Same Product Code
181
Applicant Total
35
Review Days
16
Basic Information
- Device Name
- RENAFLO II
- K Number
- K823546
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5820
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- RENAL SYSTEMS, INC.
- Date Received
- November 30, 1982
- Decision Date
- December 16, 1982
- Product Code
- KOC
- 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 |
|---|---|---|---|
| KOC | Accessories, Blood Circuit, Hemodialysis | FDA class 2 | Gastroenterology, Urology |
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Other Clearances by RENAL SYSTEMS, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K970648 | PRIMUS HOLLOW FIBER DIALYZER (MODELS 1000,1000S,1350,1350S,2000,2000S) | Jan 5, 1998 | Substantially Equivalent |
| K861730 | ACTRIL FOR KIDNEY MACHINE DISINFECTANT | Jun 9, 1987 | Substantially Equivalent |
| K854011 | RENALFO HEMOFILTER CAVHD | Nov 5, 1985 | Substantially Equivalent |
| K844790 | RENAFLO HEMOCONCENTRATOR | May 23, 1985 | Substantially Equivalent |
| K843963 | DIALYSATE CONCENTRATE FOR HEMODIALYSIS-LIQUID/POWD | Jan 7, 1985 | Substantially Equivalent |
| K844108 | RENAL SYSTEMS PERITONEAL ACCESS SYSTEM | Jan 7, 1985 | Substantially Equivalent |
| K842258 | RENATRON | Jul 6, 1984 | Substantially Equivalent |
| K841543 | CONCENTRATE CONDUCTIVITY METER | May 22, 1984 | Substantially Equivalent |
| K840182 | RENAPAK CONCENTRATE MIXING SYS. | May 2, 1984 | Substantially Equivalent |
| K840436 | HEMASITE/RENALOY -VASCULAR ACCESS SHUNT | Feb 21, 1984 | Substantially Equivalent |