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510(k) K910583

U.S. MEDICAL PS-3000 NEONATAL SCALE by U.S. Medical Corp. — Product Code FRW

K910583 is an FDA 510(k) premarket notification submitted by U.S. Medical Corp. for the device "U.S. MEDICAL PS-3000 NEONATAL SCALE". The FDA issued a decision of Substantially Equivalent on March 21, 1991. The device falls under product code FRW (Scale, Patient), a Class I device regulated under 21 CFR 880.2720. U.S. Medical Corp. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 21, 1991
Date Received
February 11, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Scale, Patient
Device Class
Class I
Regulation Number
880.2720
Review Panel
HO
Submission Type

Other clearances by U.S. Medical Corp.

  • K934677 — U. S. MEDICAL PS-3500 WARMER/INCUBATOR SCALE (July 5, 1994)
  • K924440 — U.S. MEDICAL PS-7000 DIALYSIS SCALE (May 26, 1993)
  • K924441 — U.S. MEDICAL PS-6000 WHEELCHAIR SCALE (February 12, 1993)
  • K910581 — U.S. MEDICAL PS-1000 PEDIATRIC SCALE (March 21, 1991)
  • K910582 — U.S. MEDICAL PS-2000 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 FRW

  • K955357 — OLYMPIC SMART SCALE MODEL 50/50RA (January 30, 1996)
  • K954846 — OLYMPIC SMART SCALE (December 14, 1995)
  • K955177 — OLYMPIC SMART SCALE (December 14, 1995)
  • K952649 — WARM-SCALE (August 15, 1995)
  • K943587 — ADVANCED IN-BED WEIGH SYSTEM (September 22, 1994)
  • K932572 — DIGITAL BABY SCALE MODEL BLB-12 (November 16, 1993)
  • K926174 — MODEL 9100 H.R. INFANT SCALE (October 25, 1993)
  • K926446 — EZ PUMP (September 27, 1993)
  • K926058 — 3M MODEL 280RT RATE TAPER INFUSION PUMP (August 16, 1993)
  • K926059 — 3M MODEL 200RT RATE TAPER INFUSION PUMP (August 16, 1993)

FDA data resources