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510(k) K010049

PULSECO HEMODYNAMIC MONITOR CM71 by Lidco, Ltd. — Product Code DXG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 14, 2001
Date Received
January 5, 2001
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 Lidco, Ltd.

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  • K122247 — LIDCORAPID V2 MONITOR (March 20, 2013)
  • K023960 — LIDCOPLUS HEMODYNAMIC MONITOR SYSTEM, MODEL HM 70 (January 9, 2003)
  • K962918 — LIDCO SYSTEM (January 8, 1999)

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  • K193179 — EV1000 Clinical Platform (December 17, 2019)
  • K190955 — Hypotension Decision Assist (November 27, 2019)
  • K181372 — Argos (December 13, 2018)
  • K172259 — PulsioFlex Monitoring System (January 18, 2018)
  • K163334 — LiDCOunity v2 Hemodynamic Monitor (June 5, 2017)