BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    KARL STORZ SUBGLOTTISCOPE, NEONATE AND INFANT, FIBER OPTIC LIGHT CARRIER, SUCTION TUBE

    K Number: K951804 · Decision Jun 5, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    315
    Registration Numbers
    315
    Same Product Code
    63
    Applicant Total
    334
    Review Days
    47

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    Basic Information

    Device Name
    KARL STORZ SUBGLOTTISCOPE, NEONATE AND INFANT, FIBER OPTIC LIGHT CARRIER, SUCTION TUBE
    K Number
    K951804
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    868.5540
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    KARL STORZ Endoscopy-America, Inc.
    Date Received
    April 19, 1995
    Decision Date
    June 5, 1995
    Product Code
    CCW
    Advisory Committee
    Anesthesiology
    Review Advisory Committee
    AN
    Third Party
    N

    Classifications

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

    Product Code Device Name
    CCW Laryngoscope, Rigid

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    Other Clearances by KARL STORZ Endoscopy-America, Inc.

    K Number Device Name
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    K201135 Image1 S CCU, Image1 S 4U Camera Head
    K200740 HD Video Rhino Laryngoscope
    K191357 Flexible HD Cysto-Urethroscope System
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    K182186 CMOS Video-Rhino-Laryngoscope System
    K183264 Flex-THOR scope
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