FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
GAMBRO G SERIES BLOOD LINE SETS FOR HEM.
K Number: K801016
·
Decision May 30, 1980
Classifications
1
FEI Numbers
65
Registration Numbers
65
Same Product Code
76
Applicant Total
86
Review Days
31
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Basic Information
- Device Name
- GAMBRO G SERIES BLOOD LINE SETS FOR HEM.
- K Number
- K801016
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5820
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Gambro, Inc.
- Date Received
- April 29, 1980
- Decision Date
- May 30, 1980
- Product Code
- FJK
- 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 |
|---|---|---|---|
| FJK | Set, Tubing, Blood, With And Without Anti-Regurgitation Valve | FDA class 2 | Gastroenterology, Urology |
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|---|---|---|---|
| K083158 | EXALIS, SOFTWARE VERSION 1.15 | Jun 5, 2009 | Substantially Equivalent |
| K070643 | PHOENIX HEMODIALYSIS DELIVERY SYSTEM, VERSION 3.35 | Nov 2, 2007 | Substantially Equivalent |
| K032431 | PRISMA M60/M100 SETS | Sep 15, 2003 | Substantially Equivalent |
| K896758 | GAMBRO BICARBONATE MONITOR BCM 10-3 | Sep 28, 1990 | Substantially Equivalent |
| K896757 | GAMBRO AK-10 DIALYSIS SYSTEM FOR HIGH FLOWS | Aug 30, 1990 | Substantially Equivalent |
| K902481 | GAMBRO ALWALL GFS PLUS 11, 16 & 20 HOLLOW FIBER | Jul 27, 1990 | Substantially Equivalent |
| K900918 | GAMBRO LUNDIA IC-6H PARALLEL PLATE DIALYZER | Jul 16, 1990 | Substantially Equivalent |
| K892523 | GAMBRO ALWALL GFS 11,12,PLUS 12 HOLLOW FIBER DIALY | May 11, 1989 | Substantially Equivalent |
| K890112 | ENGSTROM ELIZA + CO2 ANALYZER | Mar 15, 1989 | Substantially Equivalent |
| K890111 | GAMBRO ALWALL GFE 8 & 9 HOLLOW FIBER DIALYZER | Feb 8, 1989 | Substantially Equivalent |