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

    ULTRACHECK CURVE BLOOD PRESSURE CUFFS

    K Number: K122365 · Decision Jun 4, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    1
    Applicant Total
    2
    Review Days
    302

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    Basic Information

    Device Name
    ULTRACHECK CURVE BLOOD PRESSURE CUFFS
    K Number
    K122365
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1120
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Statcorp Medical
    Date Received
    August 6, 2012
    Decision Date
    June 4, 2013
    Product Code
    OED
    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
    OED Antimicrobial Blood Pressure Cuff

    Similar 510(k) Clearances

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

    ANTIMICROBIAL AND SINGLE-PATIENT CUFFS

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

    Other Clearances by Statcorp Medical

    K Number Device Name
    K152801 ULTRACHECK SPACELABS ABP CUFF-CHILD, ULTRACHECK SPACELABS ABP CUFF-SMALL ADULT, ULTRACHECK SPACELABS ABP CUFF-ADULT, ULTRACHECK SPACELABS ABP CUFF-LARGE ADULT