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

    ESG-1 ELECTROSONOGRAM (ESG-1)

    K Number: K970116 · Decision Apr 2, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    3
    Applicant Total
    6
    Review Days
    79

    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
    ESG-1 ELECTROSONOGRAM (ESG-1)
    K Number
    K970116
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.2050
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Myo-Tronics, Inc.
    Date Received
    January 13, 1997
    Decision Date
    April 2, 1997
    Product Code
    NFQ
    Advisory Committee
    Dental
    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
    NFQ Device, Dental Sonography, For Monitoring Jaw Sounds

    Similar 510(k) Clearances

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

    SONOPAK/QS, SONOPAK

    FDA 510(k)
    FDA Class 1 ·Dental

    ELECTROSONOGRAM ESG-1

    FDA 510(k)
    FDA Class 1 ·Dental

    ARTHROPHONOMETER

    FDA 510(k)
    FDA Class 1 ·Dental
    View all

    Other Clearances by Myo-Tronics, Inc.

    K Number Device Name
    K944134 K6-1 DIAGNOSTIC SYSTEM VERSION 3.1
    K922270 PHYSIOTECH 4000 OR NORODYN 8000
    K922456 K6-I DIAGNOSTIC SYSTEM
    K921919 MS-100 MYO-SCANNER OR MS-100 EMG SCANNER
    K905449 ELECTROSONOGRAM ESG-1