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

    MODEL DT-102 DATA TELEPHONE TRANSMITTER

    K Number: K861455 · Decision May 30, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    55
    Registration Numbers
    55
    Same Product Code
    213
    Applicant Total
    17
    Review Days
    42

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    MODEL DT-102 DATA TELEPHONE TRANSMITTER
    K Number
    K861455
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.2740
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent for Some Indications
    Applicant
    Advantage Medical Systems, Inc.
    Date Received
    April 18, 1986
    Decision Date
    May 30, 1986
    Product Code
    HGM
    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
    HGM System, Monitoring, Perinatal

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (HGM), ordered by most recent decision date.

    ANNE Maternal

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    Sonicaid Team3

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    Fetal & Maternal Monitor (F15A, F15A Air)

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    Sonicaid Team3

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    PeriCALM Patterns 3.0

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    Avalon CL Fetal & Maternal (F&M) Pod (866488), Avalon CL Fetal & Maternal (F&M) Patch (989803196341)

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology
    View all

    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
    K852518 MODIFICATION FETAL MONITOR MODEL FM-2
    K844724 FETAL TELEMETRY SYSTEM
    K842462 HOLTER SCREENING MONITOR HS-221
    K840747 TOCO DATA TELEPHONE TRANSMITTER DT100P
    K832849 FETAL MONITOR #FM-2
    Search all 17 clearances from Advantage Medical Systems, Inc. →