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510(k) K131048

LIDCO CNAP MODULE by Lidco, Ltd. — Product Code DXG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 28, 2013
Date Received
April 15, 2013
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

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  • K023960 — LIDCOPLUS HEMODYNAMIC MONITOR SYSTEM, MODEL HM 70 (January 9, 2003)
  • K010049 — PULSECO HEMODYNAMIC MONITOR CM71 (June 14, 2001)
  • K962918 — LIDCO SYSTEM (January 8, 1999)

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