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

    SINUSCOPE

    K Number: K940317 · Decision May 24, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    132
    Registration Numbers
    132
    Same Product Code
    161
    Applicant Total
    16
    Review Days
    485

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    Basic Information

    Device Name
    SINUSCOPE
    K Number
    K940317
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    874.4760
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Stephen Chakoff, Inc.
    Date Received
    January 24, 1994
    Decision Date
    May 24, 1995
    Product Code
    EOB
    Advisory Committee
    Ear, Nose, Throat
    Review Advisory Committee
    EN
    Third Party
    N

    Classifications

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

    Product Code Device Name
    EOB Nasopharyngoscope (Flexible Or Rigid)

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    Other Clearances by Stephen Chakoff, Inc.

    K Number Device Name
    K940316 HYSTERSCOPE
    K950753 CHAKOFF ENDOSCOPY (CAMERA TELEVISION ENDOSCOPIC WITHOUT AUDIO
    K951082 CHAKOFF ENDOSCOPY, RIGID ENDOSCOPE
    K950744 CHAKOFF ENDOSCOPY (RIDGID ENDOSCOPE)
    K950745 CHAKOFF ENDOSCOPY (ENDOSCOPE AND/OR ACCESSORIES)
    K950747 CHAKOFF ENDOSCOPY (LIGHT SOURCE ENDOSCOPIC XENON ARC.)
    K950746 CHAKOFF ENDOSCOPY (SET LAPAROSCOPY)
    K950748 CHAKOFF ENDOSCOPY (FIBER OPTIC LIGHT SOURCE ROUTINE)
    K945421 CHAKOFF ENDOSCOPY
    K945420 CHAKOFF ENDOSCOPY
    Search all 16 clearances from Stephen Chakoff, Inc. →