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

    REPLACEMENT BATTERIES/WELCH ALLYN #72200 POWER HANDLE

    K Number: K942244 · Decision Jun 24, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    230
    Registration Numbers
    230
    Same Product Code
    55
    Applicant Total
    12
    Review Days
    87

    Basic Information

    Device Name
    REPLACEMENT BATTERIES/WELCH ALLYN #72200 POWER HANDLE
    K Number
    K942244
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    874.4770
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    NATIONAL CUSTOM ENT., INC.
    Date Received
    March 29, 1994
    Decision Date
    June 24, 1994
    Product Code
    ERA
    Advisory Committee
    Ear, Nose, Throat
    Review Advisory Committee
    EN
    Third Party
    N

    Classifications

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

    Product Code Device Name
    ERA Otoscope

    Similar 510(k) Clearances

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

    AIO HD OTOSCOPE

    FDA 510(k)
    FDA Class 1 ·Ear, Nose, Throat

    LANTOS 3D EAR SCANNER

    FDA 510(k)
    FDA Class 1 ·Ear, Nose, Throat

    OSRAM ITOS

    FDA 510(k)
    FDA Class 1 ·Ear, Nose, Throat

    OPTUS OTOSCOPES

    FDA 510(k)
    FDA Class 1 ·Ear, Nose, Throat

    WELCH ALLYN BI-OTOSCOPE

    FDA 510(k)
    FDA Class 1 ·Ear, Nose, Throat

    WELCH ALLY OTOSCOPE

    FDA 510(k)
    FDA Class 1 ·Ear, Nose, Throat
    View all

    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
    K943680 NCE REPLACEMENT BATTERIES
    K942629 NCE REPLACEMENT BATTERIES
    K941995 NCE REPLACEMENT BATTERIES
    Search all 12 clearances from NATIONAL CUSTOM ENT., INC. →