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510(k) K961138

ESORT II + 400 SERIES MONITOR by Medical Data Electronics — Product Code DRO

K961138 is an FDA 510(k) premarket notification submitted by Medical Data Electronics for the device "ESORT II + 400 SERIES MONITOR". The FDA issued a decision of Substantially Equivalent on December 10, 1996. The device falls under product code DRO (Pacemaker, Cardiac, External Transcutaneous (Non-Invasive)), a Class II device regulated under 21 CFR 870.5550. Medical Data Electronics has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 10, 1996
Date Received
March 21, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pacemaker, Cardiac, External Transcutaneous (Non-Invasive)
Device Class
Class II
Regulation Number
870.5550
Review Panel
CV
Submission Type

Other clearances by Medical Data Electronics

  • K014294 — MODIFICATION TO ESCORT II+ 400 SERIES 9ESCORT PRISM) MONITOR, MODELS 20400, 2040 (January 25, 2002)
  • K012336 — MODIFICATION TO:ESCORT VISION CENTRAL STATION TELEMETRY SYSTEM, MODEL 20500 (October 3, 2001)
  • K000660 — ESCORT II+ 400 SERIES (ESCORT PRISM), MODEL 20400, 20401, 20403, MONITOR, MODELS (March 28, 2000)
  • K992413 — ESCORT 100/300 SERIES B (ESCORT II) PATIENT MONITOR (August 19, 1999)
  • K992411 — ESCORT II+ 400 SERIES (ESCORT PRISM) MONITOR (August 18, 1999)
  • K982104 — ESCORT-LINK CENTRAL STATION MONITOR MODEL 20500 (November 25, 1998)
  • K970763 — MODULAR TELEMETRY SYSTEM (MTS) OPTION FOR THE MDE ESCORT II MONITOR (July 14, 1997)
  • K970011 — ESCORT II CLINICAL THERMOMETRY MODULE (CTM) (July 9, 1997)
  • K970012 — ESCORT LINK CENTRAL STATION MONITOR (June 26, 1997)
  • K943256 — CARDIAC OUTPUT OPTION 39 (December 15, 1994)

Other clearances for product code DRO

  • K012404 — K-DEFIB/PACE ADULT ELECTRODE, MODEL KDP-85 (October 12, 2001)
  • K012218 — LUDLOW GRADIENT EDGE ADULT & PEDIATRIC MULTIFUNCTIONAL ELECTRODES (October 12, 2001)
  • K000660 — ESCORT II+ 400 SERIES (ESCORT PRISM), MODEL 20400, 20401, 20403, MONITOR, MODELS (March 28, 2000)
  • K983232 — PADTAK PEDIATRIC DEFIB/CARDIOVERT/PACE/MONITOR-RADIOTRANSPARENT (2X2.25),MODEL 2 (September 15, 1999)
  • K983196 — PADTAK PACE/DEFIB/CARDIOVERT MONITORING ELECTRODE(S) (September 15, 1999)
  • K974034 — PORTABLE INTENSIVE CARE UNIT (March 2, 1998)
  • K962547 — CARDIOSERV P (March 6, 1997)
  • K963120 — RESPONDER 2500 DEFIBRILLATOR AND CARDIAC CARE SYSTEM (February 28, 1997)
  • K951593 — LIFEPAK 11 (December 29, 1995)
  • K950856 — ZOLL PD2000 PACEMAKER/ADVISORY DEFIBRILLATOR, MODEL PD2000, ZOLL D2000 ADVISORY (December 29, 1995)

FDA data resources