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Medical Data Electronics

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
27
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K014294MODIFICATION TO ESCORT II+ 400 SERIES 9ESCORT PRISM) MONITOR, MODELS 20400, 20401, 20403, 20411, 204January 25, 2002
K012336MODIFICATION TO:ESCORT VISION CENTRAL STATION TELEMETRY SYSTEM, MODEL 20500October 3, 2001
K000660ESCORT II+ 400 SERIES (ESCORT PRISM), MODEL 20400, 20401, 20403, MONITOR, MODELS 20411, 20412, 20413March 28, 2000
K992413ESCORT 100/300 SERIES B (ESCORT II) PATIENT MONITORAugust 19, 1999
K992411ESCORT II+ 400 SERIES (ESCORT PRISM) MONITORAugust 18, 1999
K982104ESCORT-LINK CENTRAL STATION MONITOR MODEL 20500November 25, 1998
K970763MODULAR TELEMETRY SYSTEM (MTS) OPTION FOR THE MDE ESCORT II MONITORJuly 14, 1997
K970011ESCORT II CLINICAL THERMOMETRY MODULE (CTM)July 9, 1997
K970012ESCORT LINK CENTRAL STATION MONITORJune 26, 1997
K961138ESORT II + 400 SERIES MONITORDecember 10, 1996
K943256CARDIAC OUTPUT OPTION 39December 15, 1994
K930524END TIDAL CO2 OPTION BFebruary 7, 1994
K930004ESCORT 100/300 SERIES B PATIENT MONITORSJune 23, 1993
K915153ESCORT-LINK ARRHYTHMIA OPTION 23LApril 27, 1992
K914458ESCORT 300A SERIES DEFIBRILLATOR/PACER OPTIONDecember 9, 1991
K911665ESCORT 300 SERIESAugust 29, 1991
K902254ESCORT MODEL 400T TELEMETRY ECG MONITORJuly 27, 1990
K902060ESCORT MODEL 300June 11, 1990
K901591ESCORT-LINK (MODEL E3200)May 15, 1990
K896958ESCORT NON-INVASIVE BLOOD PRESSURE OPTIONMarch 13, 1990