FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
U.S. MEDICAL PS-7000 DIALYSIS SCALE
K Number: K924440
·
Decision May 26, 1993
Classifications
1
FEI Numbers
68
Registration Numbers
68
Same Product Code
26
Applicant Total
8
Review Days
267
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
- U.S. MEDICAL PS-7000 DIALYSIS SCALE
- K Number
- K924440
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5520
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- U.S. Medical Corp.
- Date Received
- September 1, 1992
- Decision Date
- May 26, 1993
- Product Code
- KOE
- 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 |
|---|---|---|---|
| KOE | Dilator, Urethral | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KOE), ordered by most recent decision date.
Optilume Basic Urological Balloon Dilation Catheter
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ATRION MEDICAL QL INFLATION DEVICE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ATRION MEDICAL BALLOON CATHETER INFLATION DEVICE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
BARD EAGLE INFLATION DEVICE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
AQ HYDROPHILIC DILATORS
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
120 FR OPTILUME PROSTATE BALLOON DILATOR
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Other Clearances by U.S. Medical Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K934677 | U. S. MEDICAL PS-3500 WARMER/INCUBATOR SCALE | Jul 5, 1994 | Substantially Equivalent |
| K924441 | U.S. MEDICAL PS-6000 WHEELCHAIR SCALE | Feb 12, 1993 | Substantially Equivalent |
| K910583 | U.S. MEDICAL PS-3000 NEONATAL SCALE | Mar 21, 1991 | Substantially Equivalent |
| K910581 | U.S. MEDICAL PS-1000 PEDIATRIC SCALE | Mar 21, 1991 | Substantially Equivalent |
| K910582 | U.S. MEDICAL PS-2000 PEDIATRIC SCALE | Mar 21, 1991 | Substantially Equivalent |
| K896633 | AUTO-CUFF(TM) | Feb 1, 1990 | Substantially Equivalent |
| K801053 | PULSED GALVANIC STIMULATOR, 450-DYNAMAX | Jun 4, 1980 | Substantially Equivalent |