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

    NCE REPLACEMENT BATTERIES

    K Number: K943680 · Decision Nov 4, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    19
    Applicant Total
    12
    Review Days
    101

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    Basic Information

    Device Name
    NCE REPLACEMENT BATTERIES
    K Number
    K943680
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    National Custom Ent., Inc.
    Date Received
    July 26, 1994
    Decision Date
    November 4, 1994
    Product Code
    FCO
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    FCO Box, Battery, Rechargeable

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    Other Clearances by National Custom Ent., Inc.

    K Number Device Name
    K012264 MARQUETTE MAC8, MAC PERSONAL, MAC STRESS, MODEL N3043IWC
    K012263 MARQUETTE EAGLE MONITOR MODEL 4000, MODEL N3024
    K012262 BAXTER AS40A, AS41 SYRINGE PUMP, MODEL N61WC
    K012259 MEDFUSION 2001 & 2010, MODEL N7215IWC
    K012266 SHERWOOD 224, 324 FEEDING PUMP & K524 INTRI-FLUSH, MODEL N7213IWC2
    K012229 SCALE-TRONIX 48, 2001, 2009,2700,3003,4004, 4800, 5005,5700,6005,6500,6700,6006C & 20009, MODEL N661WC
    K943632 REPLACEMENT BATTERIES
    K942629 NCE REPLACEMENT BATTERIES
    K941995 NCE REPLACEMENT BATTERIES
    K942244 REPLACEMENT BATTERIES/WELCH ALLYN #72200 POWER HANDLE
    Search all 12 clearances from National Custom Ent., Inc. →