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

    MEC-1 VIDEO COMBO SYSTEM

    K Number: K883944 · Decision Sep 28, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    12
    Registration Numbers
    12
    Same Product Code
    1
    Applicant Total
    5
    Review Days
    9

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    Basic Information

    Device Name
    MEC-1 VIDEO COMBO SYSTEM
    K Number
    K883944
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4160
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Medical Concepts, Inc.
    Date Received
    September 19, 1988
    Decision Date
    September 28, 1988
    Product Code
    FTS
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    FTS Camera, Cine, Endoscopic, With Audio

    Similar 510(k) Clearances

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

    CCM-1 VIDEO CAMERA SYSTEM

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery
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    Other Clearances by Medical Concepts, Inc.

    K Number Device Name
    K110659 MEDICAL CONCEPTS INTERBODY FUSION SYSTEM
    K940283 KARL STORZ ENDOVISION UROCAM/HYSTEROCAM
    K883943 CCM-1 VIDEO CAMERA SYSTEM
    K802564 MEDICAL MAGNETIC TAPE RECORDER