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

    WESCOR MODEL 3700 WEBSTER SWEAT INDUCER

    K Number: K853973 · Decision Oct 16, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    15
    Applicant Total
    13
    Review Days
    20

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    Basic Information

    Device Name
    WESCOR MODEL 3700 WEBSTER SWEAT INDUCER
    K Number
    K853973
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.5525
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Applicant
    Wescor, Inc.
    Date Received
    September 26, 1985
    Decision Date
    October 16, 1985
    Product Code
    KTB
    Advisory Committee
    Physical Medicine
    Review Advisory Committee
    PM
    Third Party
    N

    Classifications

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

    Product Code Device Name
    KTB Device, Iontophoresis, Specific Uses

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    Other Clearances by Wescor, Inc.

    K Number Device Name
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    K010031 NANODUCT NEONATAL SWEAT ANALYSIS SYSTEM
    K863395 WESCOR SWEAT.CHEK SWEAT CONDUCTIVITY ANALYZER
    K881592 WESCOR MODEL 7300 AEROSPRAY GRAM STAINER
    K881512 WESCOR GRAM STAIN PACK FOR MODEL 7300 AEROSPRAY
    K880544 WESCOR STAIN CONCENTRATE FOR MODEL 7100 AEROSPRAY
    K834214 WESCOR 5500 VAPOR PRESSURE OSMOMETER
    K834208 COLLOID OSMOMETER 4400
    K840472 SYS MACRODUCT SWEAT COLLECTION SYS 3600
    K833295 WESCOR 7100 AEROSPRAY SLIDE STAINER
    Search all 13 clearances from Wescor, Inc. →