FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DELMED 80/2 DIALYSIS SYSTEM W/LAST BAG OPTION
K Number: K901478
·
Decision Jul 27, 1990
Classifications
1
FEI Numbers
38
Registration Numbers
38
Same Product Code
82
Applicant Total
27
Review Days
122
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Basic Information
- Device Name
- DELMED 80/2 DIALYSIS SYSTEM W/LAST BAG OPTION
- K Number
- K901478
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5630
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Delmed, Inc.
- Date Received
- March 27, 1990
- Decision Date
- July 27, 1990
- Product Code
- FKX
- 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 |
|---|---|---|---|
| FKX | System, Peritoneal, Automatic Delivery | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
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Archimedes Pro Automated Peritoneal Dialysis Cycler (3014-00000-1); Archimedes Standard Automated Peritoneal Dialysis Cycler (3014-00000-3); Archimedes Pro Disposable Tubing Set (3014-50000-1); Archimedes Standard Disposable Tubing Set (3014-50000-3); Archimedes Pro Plus Disposable Tubing Set (3014-50000-5)
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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 |
| K894506 | ENTERA-FLO ENTERAL FEEDING PUMP | Aug 6, 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 |