FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PRISMA CFM (CONTINUOUS FLUID MANAGEMENT SYSTEM)
K Number: K946279
·
Decision Feb 10, 1997
Classifications
1
FEI Numbers
81
Registration Numbers
81
Same Product Code
336
Applicant Total
14
Review Days
776
Basic Information
- Device Name
- PRISMA CFM (CONTINUOUS FLUID MANAGEMENT SYSTEM)
- K Number
- K946279
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5860
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- COBE RENAL CARE, INC.
- Date Received
- December 27, 1994
- Decision Date
- February 10, 1997
- 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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FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Other Clearances by COBE RENAL CARE, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K955497 | GAMBRO FH 22H FIBER HEMOFLTR/PRISMA FH 22H BLOOD TUBING/HEMOFLTR SET | Sep 25, 1997 | Substantially Equivalent |
| K955592 | COBE CENTRYSYSTEM 14 PES HEMODIALYZERS | Apr 30, 1997 | Substantially Equivalent |
| K955487 | GAMBRO POLYFLUX 14, 17, & 21 HEMODIALYZERS | Apr 18, 1997 | Substantially Equivalent |
| K954003 | COBE HEMODYNAMIC RECIRCULATION MONITOR | Feb 6, 1997 | Substantially Equivalent |
| K960474 | COBE CENTRYSYSTEM 600 HG HEMODIALYZERS | Aug 14, 1996 | Substantially Equivalent |
| K944436 | COBE CENTRYSYSTEM CS 200 DIALYZER | Jan 29, 1996 | Substantially Equivalent |
| K951311 | GAMBRO HC 14R HEMOCONCENTRATOR | Jan 11, 1996 | Substantially Equivalent |
| K952342 | GAMBRO LUNDIA 94-700 & SIGMA 800 HEMODIALYZERS | Sep 15, 1995 | Substantially Equivalent |
| K945746 | GAMBRO LUNDIA 94-500 DIALYZER | Sep 8, 1995 | Substantially Equivalent |
| K945747 | GAMBRO LUNDIA 94-600 DIALYZER | Sep 8, 1995 | Substantially Equivalent |