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

    VitalRhythm

    K Number: K242129 · Decision Apr 17, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    178
    Registration Numbers
    178
    Same Product Code
    429
    Applicant Total
    10
    Review Days
    269

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    Basic Information

    Device Name
    VitalRhythm
    K Number
    K242129
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1425
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Vitalconnect, Inc.
    Date Received
    July 22, 2024
    Decision Date
    April 17, 2025
    Product Code
    DQK
    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
    DQK Computer, Diagnostic, Programmable

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    Other Clearances by Vitalconnect, Inc.

    K Number Device Name
    K193343 Vista Solution Monitoring Kit, Vista Solution 2 10-day Evaluation Kit, VistaTablet 2 (Boxed)
    K192757 VitalPatch 5D Biosensor - single, VitalPatch 7D Biosensor - single, VitalPatch 5D Biosensor – bag of 20, VitalPatch 7D Biosensor – bag of 20
    K190916 VitalPatch 7D Biosensor - single, VitalPatch 7D Biosensor - bag of 20
    K183078 VitalConnect Platform, VitalPatch Biosensor
    K163453 VitalPatch® VitalConnect Platform
    K170973 VitalWatch Software User Interface
    K152139 Vital Connect Platform, HealthPatch MD, VitalPatch
    K141167 VITALCONNECT PLATFORM (CONSISTING OF VITALCONNECT SENSOR, RELAY SOFTWARE LIBRARY AND SECURE SERVER SOFTWARE LIBRARY)
    K132447 VITALCONNECT PLATFORM BY VITAL CONNECT INC.