BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent - Subject to Tracking Reg. 🇺🇸 United States

    NCE REPLACEMENT BATTERIES

    K Number: K941995 · Decision Jul 26, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    36
    Registration Numbers
    36
    Same Product Code
    165
    Applicant Total
    12
    Review Days
    92

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    Basic Information

    Device Name
    NCE REPLACEMENT BATTERIES
    K Number
    K941995
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.5300
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent - Subject to Tracking Reg.
    Applicant
    National Custom Ent., Inc.
    Date Received
    April 25, 1994
    Decision Date
    July 26, 1994
    Product Code
    LDD
    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
    LDD Dc-Defibrillator, Low-Energy, (Including Paddles)

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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
    K943680 NCE REPLACEMENT BATTERIES
    K943632 REPLACEMENT BATTERIES
    K942629 NCE REPLACEMENT BATTERIES
    K942244 REPLACEMENT BATTERIES/WELCH ALLYN #72200 POWER HANDLE
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