FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ENTERA-FLO ENTERAL FEEDING PUMP
K Number: K894506
·
Decision Aug 6, 1990
Classifications
1
FEI Numbers
149
Registration Numbers
149
Same Product Code
847
Applicant Total
27
Review Days
383
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Basic Information
- Device Name
- ENTERA-FLO ENTERAL FEEDING PUMP
- K Number
- K894506
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5725
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Delmed, Inc.
- Date Received
- July 19, 1989
- Decision Date
- August 6, 1990
- Product Code
- FRN
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| FRN | Pump, Infusion | FDA class 2 | General Hospital |
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Other Clearances by Delmed, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K895142 | ENTERAL PUMP SET WITH ENTERAL SPIKE | Oct 2, 1990 | Substantially Equivalent |
| K895650 | ENTERAL PUMP SET W/ENTERA-FLO SPIKE | Oct 2, 1990 | Substantially Equivalent |
| K895329 | 600ML AND 1200ML ENTERAL BAG ADM. SET FOR ENTERA | Oct 2, 1990 | Substantially Equivalent |
| K901478 | DELMED 80/2 DIALYSIS SYSTEM W/LAST BAG OPTION | Jul 27, 1990 | Substantially Equivalent |
| K901477 | DELMED 80/2 DIALYSIS SYSTEM W/ULTRAFILTRATION | Jul 27, 1990 | Substantially Equivalent |
| K900106 | CLOSED DISCONNECT SYSTEM | Jul 16, 1990 | Substantially Equivalent |
| K895246 | FRENTA(R) DUO-SET | May 2, 1990 | Substantially Equivalent |
| K895330 | 600ML AND 1200ML ENTERAL BAG ADM. SET FOR FRENTA | May 2, 1990 | Substantially Equivalent |
| K895919 | ENTERAL BAG ADMINI. SETS FOR USE W/FLEXIFLO-III | May 2, 1990 | Substantially Equivalent |
| K895696 | ENTERAL PUMP SET W/ENTERAL SPIKE FOR USE W/FEED PU | May 2, 1990 | Substantially Equivalent |