BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇮🇱 Israel

    ELCAM VITAL SIGNS WIRELESS SYSTEM (VSWS)

    K Number: K120253 · Decision Jul 16, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    125
    Registration Numbers
    125
    Same Product Code
    190
    Applicant Total
    16
    Review Days
    171

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    Basic Information

    Device Name
    ELCAM VITAL SIGNS WIRELESS SYSTEM (VSWS)
    K Number
    K120253
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2910
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Elcam Medical Acal
    Date Received
    January 27, 2012
    Decision Date
    July 16, 2012
    Product Code
    DRG
    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
    DRG Transmitters And Receivers, Physiological Signal, Radiofrequency

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    Other Clearances by Elcam Medical Acal

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    K123084 DISPOSABLE HIGH PRESSURE STOPCOCK/MANIFOLD MODEL HP STOPCOCK, MP STOPCOCK, HP MANIFOLD, PHP MANIFOLD
    K120624 ELCAM DISPOSABLE INTEGRATED PRESSURE TRANSDUCER (DIPT)
    K111467 FLEXI-Q DV AND DVR AUTO-INJECTORS
    K111016 SAFEPORT MANIFOLD (TM) (OR STOPCOCK)
    K100425 HASKAL TORQUE DEVICE
    K082106 ELCAM ANTIMICROBIAL CLOSED STOPCOCKS (DSS AND TSS)
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