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510(k) K982104

ESCORT-LINK CENTRAL STATION MONITOR MODEL 20500 by Medical Data Electronics — Product Code MLD

K982104 is an FDA 510(k) premarket notification submitted by Medical Data Electronics for the device "ESCORT-LINK CENTRAL STATION MONITOR MODEL 20500". The FDA issued a decision of Substantially Equivalent on November 25, 1998. The device falls under product code MLD (Monitor, St Segment With Alarm), a Class II device regulated under 21 CFR 870.1025. Medical Data Electronics has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 25, 1998
Date Received
June 15, 1998
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Monitor, St Segment With Alarm
Device Class
Class II
Regulation Number
870.1025
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)
  • 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)
  • K961138 — ESORT II + 400 SERIES MONITOR (December 10, 1996)
  • K943256 — CARDIAC OUTPUT OPTION 39 (December 15, 1994)

Other clearances for product code MLD

  • K101602 — VITAL SIGNS MONITOR (September 1, 2010)
  • K080461 — STAR ST AND ARRHYTHMIA SOFTWARE, RELEASE J.0 (March 13, 2008)
  • K022740 — DATEX-OHMEDA S/5 COMPACT CRITICAL CARE MONITOR WITH L-CICU02 & L-CICU02A SOFTWAR (November 14, 2002)
  • K012837 — MODIFICATION TO: DATEX-OHMEDA CARDIOCAP 5 (REV B) AND ACCESSORIES (September 14, 2001)
  • K002105 — SIEMENS INFINITY SC 6002XL ENHANCED WITH ST SEGMENT ANALYSIS (December 5, 2000)
  • K992323 — DATEX-OHMEDA CARDIOCAP 5, F-MX, F-MXG AND ACCESSORIES (November 1, 1999)
  • K974492 — SIEMENS SC6000/SC6000P BEDSIDE MONITORING SYSTEM ENHANCED WITH ST SEGMENT ANALYS (February 26, 1998)
  • K972121 — ACUITY CENTRAL STATION (November 7, 1997)
  • K953175 — AS/3 ESTPR MODULE (February 6, 1997)
  • K960272 — EAGLE 3000/3100 PATIENT MONITOR (October 2, 1996)

FDA data resources