FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
GAMBRO PRESSURE MONITOR GUARDS
K Number: K851230
·
Decision Apr 9, 1985
Classifications
1
FEI Numbers
21
Registration Numbers
21
Same Product Code
34
Applicant Total
86
Review Days
14
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- GAMBRO PRESSURE MONITOR GUARDS
- K Number
- K851230
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5820
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Gambro, Inc.
- Date Received
- March 26, 1985
- Decision Date
- April 9, 1985
- Product Code
- FIB
- 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 |
|---|---|---|---|
| FIB | Protector, Transducer, Dialysis | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FIB), ordered by most recent decision date.
NovaLine SP-C35 Transducer Protector (956007)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
NIPRO TRANSDUCER PROTECTOR TP-SURE, MODEL TPSURE+1
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
HEMODIALYSIS TUBING SETS
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
NIPRO BLOOD TUBING SET FOR HEMODIALYSIS WITH TRANSDUCER PROTECTORS AND PRIMING SET
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
NIPRO BLOOD TUBING SET FOR HEMODIALYSIS WITH TRANSDUCER PROTECTORS AND PRIMING SET
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
FRESENIUS VIRAL BLOCKING TRANSDUCER PROTECTOR FOR HEMODIALYSIS, MODEL 04-9500-2
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Other Clearances by Gambro, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| 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 |