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
KOE Dilator, Urethral

Similar 510(k) Clearances

Other 510(k) clearances with the same product code (KOE), ordered by most recent decision date.

View all

Other Clearances by U.S. Medical Corp.

K Number Device Name
K934677 U. S. MEDICAL PS-3500 WARMER/INCUBATOR SCALE
K924441 U.S. MEDICAL PS-6000 WHEELCHAIR SCALE
K910583 U.S. MEDICAL PS-3000 NEONATAL SCALE
K910581 U.S. MEDICAL PS-1000 PEDIATRIC SCALE
K910582 U.S. MEDICAL PS-2000 PEDIATRIC SCALE
K896633 AUTO-CUFF(TM)
K801053 PULSED GALVANIC STIMULATOR, 450-DYNAMAX