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

    PHONIC EAR, MODEL 841L

    K Number: K800340 · Decision Feb 26, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    101
    Registration Numbers
    101
    Same Product Code
    1366
    Applicant Total
    10
    Review Days
    11

    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
    PHONIC EAR, MODEL 841L
    K Number
    K800340
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    874.3300
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Applicant
    Hc Electronics
    Date Received
    February 15, 1980
    Decision Date
    February 26, 1980
    Product Code
    ESD
    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
    ESD Hearing Aid, Air-Conduction, Prescription

    Similar 510(k) Clearances

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

    Lyric4 Hearing Aid

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

    LYRIC2

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

    LYRIC HEARING AID

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

    INSOUND XT SERIES HEARING AID

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

    TCI COMBI (TINNITUS CONTROL INSTRUMENT COMBINATION)

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

    SONIC INNOVATIONS COMPLETELY-IN-THE-CANAL DSP HEARING AID WITH SOFT SHELL

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

    Other Clearances by Hc Electronics

    K Number Device Name
    K810031 STEREO AUDITORY TRAINER (MODEL PM228)
    K810030 POST-AURICULAR HEARING AID (#PE830)
    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