FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
RINSE MACHINE KR-4 KIDNEY RINSE-4
K Number: K850799
·
Decision Jul 29, 1985
Classifications
1
FEI Numbers
7
Registration Numbers
7
Same Product Code
56
Applicant Total
3
Review Days
152
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
- RINSE MACHINE KR-4 KIDNEY RINSE-4
- K Number
- K850799
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5820
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Medical Technologies International, Inc.
- Date Received
- February 27, 1985
- Decision Date
- July 29, 1985
- Product Code
- LIF
- 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 |
|---|---|---|---|
| LIF | Dialyzer Reprocessing System | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LIF), ordered by most recent decision date.
CLEARFLUX DIALYZER REPROCESSING SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ASSIST HEADER CLEANER
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
STERICHEK GLUTARALDEHYDE REAGENT STRIPS
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
RENACLEAN SH DIALYZER CLEANING SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
MAKY 21.1 DIALYZER REPROCESSING SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ARM AUTOMATIC REPROCESSING MACHINE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology