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510(k) K870150

CONTINUOUS CARDIAC OUTPUT MONITORING SYSTEM by Cardio Metrics, Inc. — Product Code JOP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 7, 1987
Date Received
January 13, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Transducer, Ultrasonic
Device Class
Class II
Regulation Number
870.2880
Review Panel
CV
Submission Type

Other clearances by Cardio Metrics, Inc.

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  • K951567 — CARDIOMETICS FLOWIRE, SMARTWIRE DOPPLER GUIDE WIRE (October 25, 1996)
  • K961777 — ACCUTRAC XT INTRAVASCULAR GUIDE WIRE (FLOPPY) MODEL 2403/(FLEX) MODEL 2404 (July 31, 1996)
  • K955551 — CARDI0METRICS FLOW WIRE XT DOPPLER GUIDE MODEL 1403, 1404 (February 28, 1996)
  • K954913 — CARDIOMETRICS ACCUTRAC INTRAVASCULAR GUIDE WIRE (MODIFICATION) (November 7, 1995)
  • K952562 — CARDIOMETRICS ACCUTRAC INTRAVASCULAR GUIDE WIRE (August 29, 1995)
  • K943022 — CARDIOMETRICS FLOWIRE DOPPLER GUIDE WIRE (September 19, 1994)
  • K940984 — CARDIOMETRICS DUALFLOW SWITCH BOX (August 18, 1994)
  • K933320 — CARDIOMETRICS FLOMAP AND FLOMOD ULTRASOUND INSTRUMENT (August 17, 1994)

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