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510(k) K934677

U. S. MEDICAL PS-3500 WARMER/INCUBATOR SCALE by U.S. Medical Corp. — Product Code FMT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 5, 1994
Date Received
September 28, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Warmer, Infant Radiant
Device Class
Class II
Regulation Number
880.5130
Review Panel
HO
Submission Type

Other clearances by U.S. Medical Corp.

  • K924440 — U.S. MEDICAL PS-7000 DIALYSIS SCALE (May 26, 1993)
  • K924441 — U.S. MEDICAL PS-6000 WHEELCHAIR SCALE (February 12, 1993)
  • K910582 — U.S. MEDICAL PS-2000 PEDIATRIC SCALE (March 21, 1991)
  • K910581 — U.S. MEDICAL PS-1000 PEDIATRIC SCALE (March 21, 1991)
  • K910583 — U.S. MEDICAL PS-3000 NEONATAL SCALE (March 21, 1991)
  • K896633 — AUTO-CUFF(TM) (February 1, 1990)
  • K801053 — PULSED GALVANIC STIMULATOR, 450-DYNAMAX (June 4, 1980)

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