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510(k) K970763

MODULAR TELEMETRY SYSTEM (MTS) OPTION FOR THE MDE ESCORT II MONITOR by Medical Data Electronics — Product Code DQA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 14, 1997
Date Received
March 3, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Oximeter
Device Class
Class II
Regulation Number
870.2700
Review Panel
AN
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)
  • 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)

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