FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
FRESENIUS ULTRAFLUX AV400, AV600
K Number: K864587
·
Decision Mar 3, 1987
Classifications
1
FEI Numbers
89
Registration Numbers
89
Same Product Code
343
Applicant Total
21
Review Days
102
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Basic Information
- Device Name
- FRESENIUS ULTRAFLUX AV400, AV600
- K Number
- K864587
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5860
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Seratronics, Inc.
- Date Received
- November 21, 1986
- Decision Date
- March 3, 1987
- Product Code
- KDI
- 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 |
|---|---|---|---|
| KDI | Dialyzer, High Permeability With Or Without Sealed Dialysate System | FDA class 2 | Gastroenterology, Urology |
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Other Clearances by Seratronics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K955299 | DPS 4 DIALYZER PREPARATION SYSTEM | Oct 21, 1996 | Substantially Equivalent |
| K931336 | DRS 4 DIALYZER REPROCESSING SYSTEM | Apr 18, 1996 | Substantially Equivalent |
| K944539 | DRS 4 ND DIALYZER REPROCESSING SYSTEM | Nov 29, 1995 | Substantially Equivalent |
| K923529 | DMS DATA MANAGEMENT SYSTEM/DRS-4 DIALYZER REPROCES | Aug 29, 1994 | Substantially Equivalent |
| K914580 | DRS-4 DIALYZER REPROCESSING SYSTEM | Feb 24, 1992 | Substantially Equivalent |
| K874573 | FRESENIUS PURISTERIL 340 (TM) | Apr 25, 1988 | Substantially Equivalent |
| K874872 | FRESENIUS HEMOFLOW F3, F4, F5, F7 | Feb 19, 1988 | Substantially Equivalent |
| K870725 | FRESENIUS HEMOFLOW F6 AND F8 | May 1, 1987 | Substantially Equivalent |
| K870724 | FRESENIUS HEMOFLOW F60 AND F80 | Apr 1, 1987 | Substantially Equivalent |
| K864169 | FRESENIUS HEMOFLOW F50 & F70 | Nov 6, 1986 | Substantially Equivalent |