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510(k) K841967

DESERET THERMODILUTION CARDIAC OUTPUT by Parke-Davis Co. — Product Code DXG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 19, 1985
Date Received
May 15, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Computer, Diagnostic, Pre-Programmed, Single-Function
Device Class
Class II
Regulation Number
870.1435
Review Panel
CV
Submission Type

Other clearances by Parke-Davis Co.

  • K861725 — INTRACATH INTRAVENOUS CATHETER PLACEMENT UNIT (December 4, 1986)
  • K862119 — DESERET FLO-THRU INJECTATE TEMPERATURE SENSOR (August 29, 1986)
  • K855120 — ATI DISPOSABLE BIOLOGICAL TEST PACK (June 18, 1986)
  • K860570 — ANGIO-FLO CONTINUOUS ARTERIAL CATH FLUSH DEVICE (March 31, 1986)
  • K860290 — VIAPIC CENTRAL LINE CATHETER (March 18, 1986)
  • K852192 — DISPOSABLE STEAM BIOLOGICAL TEST PACK (November 1, 1985)
  • K851327 — DESERET ARTERIAL CATHETER (June 14, 1985)
  • K852078 — SPECTRUM(TENTATIVE) (June 7, 1985)
  • K844840 — DESERET INTRODUCER SET (May 16, 1985)
  • K850505 — DESERET EPIDURAL CATHETER W/TOUGHY-BORST ADAPTER (March 11, 1985)

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