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510(k) K840009

NOVA 12 CARDIAC OUTPUT COMPUTER by Nova Medical Specialties — Product Code DXG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 22, 1984
Date Received
January 4, 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 Nova Medical Specialties

  • K872770 — DUAL-THERMISTOR THERMODILUTION CATH. & INFU. CATH. (October 15, 1987)
  • K860526 — NOVA BALLOON THERMODILUTION PRESSURE TRANS CATH (May 2, 1986)
  • K853625 — NOVA ARTERIAL EMBOLECTOMY CATHETER (January 15, 1986)
  • K841639 — NOVA BALLOON THERMODILUTION CATH. (August 12, 1984)
  • K841640 — NOVA BALLOON THERMODILUTION INFUSION (August 12, 1984)
  • K834037 — HEPARIN COATED BALLOON THERMODILU (January 10, 1984)
  • K834036 — HEPARIN COATED BALLOON THERMODILU (January 10, 1984)
  • K832287 — NOVA BALLOON THERMODILUTION INFUSION (October 19, 1983)
  • K822806 — BALLOON WEDGE PRESSURE, ANGIOGRAPHIC (November 1, 1982)
  • K812761 — FLOW-DIRECTED BALLOON THERMODILUTION (November 2, 1981)

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