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

    OSCILLOMATE NON-INVASIVE BLOOD PRESSURE MONITOR

    K Number: K972020 · Decision May 5, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    4
    Applicant Total
    32
    Review Days
    337

    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
    OSCILLOMATE NON-INVASIVE BLOOD PRESSURE MONITOR
    K Number
    K972020
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1270
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Cas Medical Systems, Inc.
    Date Received
    June 2, 1997
    Decision Date
    May 5, 1998
    Product Code
    DXW
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

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

    Product Code Device Name
    DXW System, Phonocatheter, Intracavitary

    Similar 510(k) Clearances

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

    NEWMED ABP-LITE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MILLAR MIKRO-TIP CATHETER PHONOTRANS

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MODEL 412 ELECTROFLUIDIC MANOMETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    INFRASONDE AUTO/INFLATOR ELEC. VIBRATOR

    FDA 510(k)
    FDA Class 2 ·Cardiovascular
    View all

    Other Clearances by Cas Medical Systems, Inc.

    K Number Device Name
    K190270 FORE-SIGHT ELITE Tissue Oximeter Module
    K180003 FORE-SIGHT ELITE Module Tissue Oximeter
    K150620 740 SELECT
    K143675 FORE-SIGHT Elite Absolute Tissue Oximeter
    K140430 740 SELECT
    K133879 FORE-SIGHT ELITE ABSOLUTE TISSUE OXIMETER
    K130411 740 SELECT
    K123700 FORE-SIGHT ELITE ABSOLUTE TISSUE OXIMETER
    K112820 FORE-SIGHT ABSOLUTE TISSUE OXIMETER
    K094030 FORE-SIGHT ABSOLUTE CEREBRAL AND SOMATIC OXIMETER, MC 2000 SERIES, MODELS MC2000, MC2010, MC2020, MC2030
    Search all 32 clearances from Cas Medical Systems, Inc. →