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510(k) K924440

U.S. MEDICAL PS-7000 DIALYSIS SCALE by U.S. Medical Corp. — Product Code KOE

K924440 is an FDA 510(k) premarket notification submitted by U.S. Medical Corp. for the device "U.S. MEDICAL PS-7000 DIALYSIS SCALE". The FDA issued a decision of Substantially Equivalent on May 26, 1993. The device falls under product code KOE (Dilator, Urethral), a Class II device regulated under 21 CFR 876.5520. U.S. Medical Corp. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 26, 1993
Date Received
September 1, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dilator, Urethral
Device Class
Class II
Regulation Number
876.5520
Review Panel
GU
Submission Type

Other clearances by U.S. Medical Corp.

  • K934677 — U. S. MEDICAL PS-3500 WARMER/INCUBATOR SCALE (July 5, 1994)
  • K924441 — U.S. MEDICAL PS-6000 WHEELCHAIR SCALE (February 12, 1993)
  • K910583 — U.S. MEDICAL PS-3000 NEONATAL SCALE (March 21, 1991)
  • K910582 — U.S. MEDICAL PS-2000 PEDIATRIC SCALE (March 21, 1991)
  • K910581 — U.S. MEDICAL PS-1000 PEDIATRIC SCALE (March 21, 1991)
  • K896633 — AUTO-CUFF(TM) (February 1, 1990)
  • K801053 — PULSED GALVANIC STIMULATOR, 450-DYNAMAX (June 4, 1980)

Other clearances for product code KOE

  • K191061 — Optilume Basic Urological Balloon Dilation Catheter (January 2, 2020)
  • K032840 — ATRION MEDICAL QL INFLATION DEVICE (March 3, 2004)
  • K972964 — ATRION MEDICAL BALLOON CATHETER INFLATION DEVICE (October 10, 1997)
  • K962611 — BARD EAGLE INFLATION DEVICE (October 21, 1996)
  • K961904 — AQ HYDROPHILIC DILATORS (October 18, 1996)
  • K920551 — 120 FR OPTILUME PROSTATE BALLOON DILATOR (October 28, 1992)
  • K922349 — DOWD(TM) II (August 14, 1992)
  • K920711 — ENTRAC URETHRAL BALLOON DILATATION CATHETER (May 6, 1992)
  • K913477 — APEX(TM) PROSTATIC BALLOON DILATION CATHETER (December 27, 1991)
  • K902585 — UROPLASTY TCU PROSTATIC URETHROPLASTY CATHETER (August 27, 1990)

FDA data resources