BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    TOCO DATA TELEPHONE TRANSMITTER DT100P

    K Number: K840747 · Decision Jun 19, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    15
    Registration Numbers
    15
    Same Product Code
    22
    Applicant Total
    17
    Review Days
    117

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    Basic Information

    Device Name
    TOCO DATA TELEPHONE TRANSMITTER DT100P
    K Number
    K840747
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.2720
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Applicant
    Advantage Medical Systems, Inc.
    Date Received
    February 23, 1984
    Decision Date
    June 19, 1984
    Product Code
    HFM
    Advisory Committee
    Obstetrics/Gynecology
    Review Advisory Committee
    OB
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    HFM Monitor, Uterine Contraction, External (For Use In Clinic)

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    Other Clearances by Advantage Medical Systems, Inc.

    K Number Device Name
    K873957 NON-CORING HUBER TYPE NEEDLES
    K873290 LACERATION AND INSTRUMENT TRAYS
    K863494 NEONATAL PHYSIOLOGICAL MONITOR MODEL PM 20
    K861556 MODIFIED FETAL MONITOR MODEL FM-2
    K861279 FLUORO PLUS
    K861455 MODEL DT-102 DATA TELEPHONE TRANSMITTER
    K852518 MODIFICATION FETAL MONITOR MODEL FM-2
    K844724 FETAL TELEMETRY SYSTEM
    K842462 HOLTER SCREENING MONITOR HS-221
    K832849 FETAL MONITOR #FM-2
    Search all 17 clearances from Advantage Medical Systems, Inc. →