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

    AUDIOMETER CALIBRATOR MODEL RA 310

    K Number: K780474 · Decision Mar 30, 1978
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    1
    Applicant Total
    10
    Review Days
    6

    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
    AUDIOMETER CALIBRATOR MODEL RA 310
    K Number
    K780474
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    874.1080
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Applicant
    Tracor Instruments, Inc.
    Date Received
    March 24, 1978
    Decision Date
    March 30, 1978
    Product Code
    EWA
    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
    EWA Set, Audiometer Calibration

    Similar 510(k) Clearances

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

    OTOVIEW ENDOSCOPY SYSTEM

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

    Other Clearances by Tracor Instruments, Inc.

    K Number Device Name
    K853245 TRACOR MODEL RA600 MICROPROCESSOR AUDIOMETER
    K851392 TRACOR 200 MICROPROCESSOR AUDIOMETER/TRACOR RA 200
    K822414 TRACOR RA400 AUDIOMETER
    K790903 TRACOR MODEL RA-411 MICROPROCESSOR
    K781704 STIMULATOR, TN-3001 SOMATOSENSORY
    K781743 RESPONSE SYSTEM, TN-3000
    K780749 SPEECH AUDIOMETER RA 226
    K780450 TRACOR RA 410 AUDIOMETER
    K760859 TRACOR MODEL RA 208 COMPLIANCE AUDIOM