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

    CENTRAL DISPLAY SYSTEM #CS400

    K Number: K821479 · Decision Jun 25, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    55
    Registration Numbers
    55
    Same Product Code
    213
    Applicant Total
    17
    Review Days
    38

    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
    CENTRAL DISPLAY SYSTEM #CS400
    K Number
    K821479
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.2740
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Applicant
    Advantage Medical Systems, Inc.
    Date Received
    May 18, 1982
    Decision Date
    June 25, 1982
    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
    K861455 MODEL DT-102 DATA TELEPHONE TRANSMITTER
    K852518 MODIFICATION FETAL MONITOR MODEL FM-2
    K844724 FETAL TELEMETRY SYSTEM
    K842462 HOLTER SCREENING MONITOR HS-221
    K840747 TOCO DATA TELEPHONE TRANSMITTER DT100P
    Search all 17 clearances from Advantage Medical Systems, Inc. →