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

    NCE REPLACEMENT BATTERIES

    K Number: K942629 · Decision Aug 18, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    177
    Registration Numbers
    177
    Same Product Code
    574
    Applicant Total
    12
    Review Days
    76

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    Basic Information

    Device Name
    NCE REPLACEMENT BATTERIES
    K Number
    K942629
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2340
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    National Custom Ent., Inc.
    Date Received
    June 3, 1994
    Decision Date
    August 18, 1994
    Product Code
    DPS
    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
    DPS Electrocardiograph

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    Other Clearances by National Custom Ent., Inc.

    K Number Device Name
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    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
    K943680 NCE REPLACEMENT BATTERIES
    K943632 REPLACEMENT BATTERIES
    K941995 NCE REPLACEMENT BATTERIES
    K942244 REPLACEMENT BATTERIES/WELCH ALLYN #72200 POWER HANDLE
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