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510(k) K031091

VTI 20 MHZ GATED DOPPLER by Vascular Technology Incorporated — Product Code DPW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 23, 2003
Date Received
April 7, 2003
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Flowmeter, Blood, Cardiovascular
Device Class
Class II
Regulation Number
870.2100
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)
  • K864583 — CARDIAC PERFORMANCE MONITOR (May 11, 1987)
  • 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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