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510(k) K864583

CARDIAC PERFORMANCE MONITOR by Vascular Technology Incorporated — Product Code DQK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 11, 1987
Date Received
November 20, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Computer, Diagnostic, Programmable
Device Class
Class II
Regulation Number
870.1425
Review Panel
CV
Submission Type

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  • K944764 — VTI DISPOSABLE PRESSURE DISPLAY SET (December 27, 1994)
  • K922738 — VTI OXYGEN ANALYZER (January 27, 1993)
  • K890058 — VASCULAR TECHNOLOGY UNIOX OXYGEN ALARM (November 21, 1989)
  • K883960 — GIPHY MONITOR (October 4, 1989)
  • K862114 — KHURI REGIONAL TISSUE PH MONITOR (June 25, 1986)
  • K862113 — NO. 100352 GALVANIC OXYGEN SENSOR (June 19, 1986)
  • K852275 — VASCULAR TECH # 100123 POLAROGRAPHIC OXGYEN SENSOR (June 20, 1985)

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