FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
EMPTY DIALYSATE CONTAINER
K Number: K831689
·
Decision Aug 11, 1983
Classifications
1
FEI Numbers
21
Registration Numbers
21
Same Product Code
5
Applicant Total
27
Review Days
79
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Basic Information
- Device Name
- EMPTY DIALYSATE CONTAINER
- K Number
- K831689
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 876.4730
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Delmed, Inc.
- Date Received
- May 24, 1983
- Decision Date
- August 11, 1983
- Product Code
- FKK
- 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 |
|---|---|---|---|
| FKK | Clamp, Line | FDA class 1 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FKK), ordered by most recent decision date.
TUBING CLAMP CAT#1000-A
FDA 510(k)
FDA Class 1
·Gastroenterology, Urology
NEW TRAVENOL ROLLER CLAMP-SOLUTION ADMIN. SET
FDA 510(k)
FDA Class 1
·Gastroenterology, Urology
CLAMP, TUBING, LINE
FDA 510(k)
FDA Class 1
·Gastroenterology, Urology
AMP CAPD UNISPIKE AMINISTRATION SET
FDA 510(k)
FDA Class 1
·Gastroenterology, Urology
FLOWCLAMP CAT.#1011 & 1012
FDA 510(k)
FDA Class 1
·Gastroenterology, Urology
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 |
| 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 |