BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇲🇾 Malaysia

    LATEX ULTRASONIC PROBE COVER

    K Number: K022156 · Decision Sep 11, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    398
    Registration Numbers
    399
    Same Product Code
    408
    Applicant Total
    10
    Review Days
    436

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    Basic Information

    Device Name
    LATEX ULTRASONIC PROBE COVER
    K Number
    K022156
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    892.1570
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Pleasure Latex Products Sdn. Bhd.
    Date Received
    July 2, 2002
    Decision Date
    September 11, 2003
    Product Code
    ITX
    Advisory Committee
    Radiology
    Review Advisory Committee
    RA
    Third Party
    N

    Classifications

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

    Product Code Device Name
    ITX Transducer, Ultrasonic, Diagnostic

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    Other Clearances by Pleasure Latex Products Sdn. Bhd.

    K Number Device Name
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    K021875 MALE LATEX CONDOM WITH DOTTED/RIBBED SURFACE AND COUNOUR-WALLED SHAPE (3 IN 1 ULTIMATE MALE LATEX CONDOM
    K020272 MALE LATEX CONDOM WITH RIBBED SURFACE
    K002571 MULITPLE MALE LATX CONDOM
    K001377 SPERMICIDAL LUBRICATED MALE LATEX CONDOM
    K001221 MALE LATEX COMDOM WITH DOTTED SURFACE
    K994312 MALE LATEX CONDOM 56MM
    K994311 MALE LATEX CONDOM WITH VANILLA FLAVOR
    K982380 SURE