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510(k) K914458

ESCORT 300A SERIES DEFIBRILLATOR/PACER OPTION by Medical Data Electronics — Product Code LDD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 9, 1991
Date Received
October 7, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dc-Defibrillator, Low-Energy, (Including Paddles)
Device Class
Class II
Regulation Number
870.5300
Review Panel
CV
Submission Type

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  • K982104 — ESCORT-LINK CENTRAL STATION MONITOR MODEL 20500 (November 25, 1998)
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  • K970011 — ESCORT II CLINICAL THERMOMETRY MODULE (CTM) (July 9, 1997)
  • K970012 — ESCORT LINK CENTRAL STATION MONITOR (June 26, 1997)
  • K961138 — ESORT II + 400 SERIES MONITOR (December 10, 1996)

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  • K103334 — CARDIO MED (January 18, 2011)
  • K103159 — CARDIO MED MODEL A102, H104, O101, P103, AND Z100 (January 11, 2011)
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