FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ENTERAL PUMP SET WITH ENTERA (TM)-FLO SPIKE
K Number: K895366
·
Decision May 2, 1990
Classifications
1
FEI Numbers
228
Registration Numbers
229
Same Product Code
648
Applicant Total
38
Review Days
247
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Basic Information
- Device Name
- ENTERAL PUMP SET WITH ENTERA (TM)-FLO SPIKE
- K Number
- K895366
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5980
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Fresenius USA, Inc.
- Date Received
- August 28, 1989
- Decision Date
- May 2, 1990
- Product Code
- KNT
- 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 |
|---|---|---|---|
| KNT | Tubes, Gastrointestinal (And Accessories) | FDA class 2 | Gastroenterology, Urology |
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Other Clearances by Fresenius USA, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K992275 | FRESENIUS MODIFIED F400 LOW VOLUME HEMOCONCENTRATOR F3000 & MODIFIED F400 LOW VOL HEMOCONCENTRATOR W/TUBING SET F3000TS | Aug 4, 1999 | Substantially Equivalent |
| K970700 | FRESENIUS POLYSULFONE HEMODIALYZERS, BOTH LOW AND HIGH FLUX | Sep 15, 1998 | Substantially Equivalent |
| K974584 | FRESENIUS F SERIES HEMOCONCENTRATORS F400,F500,F700,F800,F400TS,F500TS,F700S,F800TS | May 14, 1998 | Substantially Equivalent |
| K973378 | C.A.T.S CONTINUOUS AUTOTRANSFUSION SYSTEM MODEL 900500 1, AT1 AUTOTRANSFUSION SET MODEL 900 510 1, PSQ SET (DD) MODEL 61 | Nov 3, 1997 | Substantially Equivalent |
| K961465 | 2008H ON LINE CLEARANCE MONITOR | Jul 3, 1997 | Substantially Equivalent |
| K961706 | P1R PLASMA TREATMENT SET FOR USE IN PLASMAPHERESIS WITH THE FRESENIUS AS104 CELL SEPARATOR | Jul 31, 1996 | Substantially Equivalent |
| K955762 | PACKPD PERITONEAL DIALYSIS UREA KINETIC MODELING SOFTWARE PROGRAM | Jul 31, 1996 | Substantially Equivalent |
| K941460 | FRESENIUS BLOOD TEMPERATURE MONITOR | Jul 3, 1996 | Substantially Equivalent |
| K955423 | PACK H HEMODIALYSIS UREA KINETIC MODELING SOFTWARE PROGRAM | Jun 13, 1996 | Substantially Equivalent |
| K944767 | DIALYSIS MACHINE WITH DIALYSATE ULTRAFILTER | Nov 29, 1995 | Substantially Equivalent |