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510(k) K896633

AUTO-CUFF(TM) by U.S. Medical Corp. — Product Code DXN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 1, 1990
Date Received
November 22, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Measurement, Blood-Pressure, Non-Invasive
Device Class
Class II
Regulation Number
870.1130
Review Panel
CV
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)
  • 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)
  • K801053 — PULSED GALVANIC STIMULATOR, 450-DYNAMAX (June 4, 1980)

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