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

    PACING LEAD ADAPTER MODEL ACS 16

    K Number: K781622 · Decision Dec 8, 1978
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    102
    Applicant Total
    10
    Review Days
    79

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    Basic Information

    Device Name
    PACING LEAD ADAPTER MODEL ACS 16
    K Number
    K781622
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.3620
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    R.E. Brown Co., Inc.
    Date Received
    September 20, 1978
    Decision Date
    December 8, 1978
    Product Code
    DTD
    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
    DTD Pacemaker Lead Adaptor

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    Other Clearances by R.E. Brown Co., Inc.

    K Number Device Name
    K781624 PACING LEAD MODEL BUS 860, BUS 890
    K781623 PACING MODELS MUM 860, MUM 890
    K781620 PACING LEAD MODELS, MDM 1060, MDM 1090
    K781626 PACING LEAD ADAPTER, ACV 14, ACV 23
    K781621 PACING LEAD MODELS, MAM 1260 MAM 1290
    K781619 PACING LEAD MODELS SA, 350, SAM 500
    K781625 PACING LEAD MODEL MVM 860, MVM 890
    K781627 PACING LEAD ADAPTER MODEL ADB 21
    K780781 STILITH CARDIAC PACEMAKERS-M. 60 & 120