BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇩🇪 Germany

    EarlyVue VS30

    K Number: K190624 · Decision Oct 27, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    42
    Registration Numbers
    42
    Same Product Code
    5
    Applicant Total
    48
    Review Days
    230

    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
    EarlyVue VS30
    K Number
    K190624
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1100
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Philips Medizin Systeme Boeblingen GmbH
    Date Received
    March 11, 2019
    Decision Date
    October 27, 2019
    Product Code
    DSJ
    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
    DSJ Alarm, Blood-Pressure

    Similar 510(k) Clearances

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

    SureSigns VS3; SureSigns VS4

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SureSigns VS3, SureSigns VS4

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SURESIGNS VS3, SURESIGNS VS4

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SAMS 8000 CARDIOPLEGIA MONITOR

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    KELLER VITAL SIGNS MONITOR - KMS-890

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

    Other Clearances by Philips Medizin Systeme Boeblingen GmbH

    K Number Device Name
    K252726 IntelliVue Multi-Measurement Module X3 (867030); IntelliVue Patient Monitor MX100 (867033); IntelliVue MMX (867036)
    K251146 IntelliVue Patient monitors MX400, MX450, MX500, MX550
    K233440 Avalon CL Fetal & Maternal (F&M) Pod (866488), Avalon CL Fetal & Maternal (F&M) Patch (989803196341)
    K231671 IntelliVue Patient Monitor MX750 (866471), IntelliVue Patient Monitor MX850 (866470), IntelliVue 4-Slot Module Rack FMX-4 (866468)
    K230604 IntelliVue Patient Monitor MX100 (867033), IntelliVue Multi-Measurement Module X3 (867030)
    K223574 IntelliVue Patient Monitor MX400 (866060), IntelliVue Patient Monitor MX450 (866062), IntelliVue Patient Monitor MX500 (866064), IntelliVue Patient Monitor MX550 (866066)
    K210906 IntelliVue Patient Monitor MX750, IntelliVue Patient Monitor MX850, IntelliVue 4-Slot module rack FMX-4
    K212208 Philips IntelliVue GuardianSoftware (Rev. E.0X)
    K192137 IntelliVue Patient Monitor MX500, IntelliVue Patient Monitor MX550
    K182979 IntelliVue Patient Monitors MX100, MX400, MX430, MX450, MX500, MX550, IntelliVue Patient Monitors MX700, MX800, IntelliVue Patient Monitors MP5, MP5SC, Multi-Measurement Module X3
    Search all 48 clearances from Philips Medizin Systeme Boeblingen GmbH →