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

    STEREO AUDITORY TRAINER (MODEL PM228)

    K Number: K810031 · Decision Mar 4, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    31
    Applicant Total
    10
    Review Days
    57

    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
    STEREO AUDITORY TRAINER (MODEL PM228)
    K Number
    K810031
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    874.3320
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Applicant
    Hc Electronics
    Date Received
    January 6, 1981
    Decision Date
    March 4, 1981
    Product Code
    EPF
    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
    EPF Hearing Aid, Group And Auditory Trainer

    Similar 510(k) Clearances

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

    HYPERSOUND AUDIO SYSTEM (HSS)

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

    TELEX SELECT 1-40 WITH ADAPTIVE COMPRESSION

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

    INFRARED GROUP AMPLIFICATION SYSTEM, INFRARED EMITTER, INFRARED BODY WORN RECEIVER, INFRARED HEADSET RECEIVER-STEREO, IT

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

    FM RECEIVER - AUDITORY TRAINER

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

    WILLIAMS SOUND, PERSONAL FM, HEARING HELPER

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

    WILLIAMS SOUND, PERSONAL FM, HEARING HELPER

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

    Other Clearances by Hc Electronics

    K Number Device Name
    K810030 POST-AURICULAR HEARING AID (#PE830)
    K800340 PHONIC EAR, MODEL 841L
    K782053 HEARING AID, POST-AURICULAR
    K780936 PHONIC EAR
    K780363 PHONIC EAR
    K772347 PHONIC MIRROR HANDIVOICE MODEL 120
    K772346 PHONIC MIRROR HANDIVOCIE MODEL 110
    K771357 GROUP AUDITORY TRAINER HC 431R
    K771356 POST-AURICULAR HEARING AID HC 880