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

    E.W.L. P-TENS/H-WAVE FOR GENERAL DENTISTRY

    K Number: K873604 · Decision Apr 12, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    14
    Applicant Total
    6
    Review Days
    221

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    Basic Information

    Device Name
    E.W.L. P-TENS/H-WAVE FOR GENERAL DENTISTRY
    K Number
    K873604
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Applicant
    Electronic Waveform Laboratory, Inc.
    Date Received
    September 4, 1987
    Decision Date
    April 12, 1988
    Product Code
    LWM
    Advisory Committee
    Unknown
    Review Advisory Committee
    DE
    Third Party
    N

    Classifications

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

    Product Code Device Name
    LWM Device, Electrical Dental Anesthesia

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    Other Clearances by Electronic Waveform Laboratory, Inc.

    K Number Device Name
    K103738 H-WAVE
    K081998 H-WAVE SPORT
    K915230 H WAVE MUSCLE STIMULATOR
    K862121 E.W.L. P-TENS/H-WAVE
    K813601 E.W.L. P-TENS MODEL(TENS