BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇭 Switzerland

    GLASER RT450 HEARING AID TEST AND ANALYSIS SYSTEM

    K Number: K934342 · Decision Jan 21, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    15
    Registration Numbers
    15
    Same Product Code
    45
    Applicant Total
    2
    Review Days
    136

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    GLASER RT450 HEARING AID TEST AND ANALYSIS SYSTEM
    K Number
    K934342
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    874.3310
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Glaser Instruments AG
    Date Received
    September 7, 1993
    Decision Date
    January 21, 1994
    Product Code
    ETW
    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
    ETW Calibrator, Hearing Aid / Earphone And Analysis Systems

    Similar 510(k) Clearances

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

    AURICAL HIT

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    PRIMUS HEARING INSTRUMENT TEST UNIT

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    GN OTOMETRICS TYPE 1053 FREEFIT

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    FONIX ,MODEL 8000

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    UNITY 2 HIA & PROBE ( FOR USE WITH UNITY 2)

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    SPEECHLINK 100 TYPE 1053

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat
    View all

    Other Clearances by Glaser Instruments AG

    K Number Device Name
    K934343 GLASER RT60, RT80, RT150 AUDIOMETER