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

    MAICO MA630D AUDIOMETER WITH OPTIONAL REFLEX DECAY & EUSTACHIAN TUBE FUNCTION

    K Number: K953161 · Decision Jul 24, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    69
    Applicant Total
    58
    Review Days
    17

    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
    MAICO MA630D AUDIOMETER WITH OPTIONAL REFLEX DECAY & EUSTACHIAN TUBE FUNCTION
    K Number
    K953161
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    874.1090
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Maico Hearing Instruments, Inc.
    Date Received
    July 7, 1995
    Decision Date
    July 24, 1995
    Product Code
    ETY
    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
    ETY Tester, Auditory Impedance

    Similar 510(k) Clearances

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

    Hearing Healthcare Pro

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

    Hearing Healthcare Pro

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

    touchTymp

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

    Madsen Zodiac

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

    AT235

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

    GSI TympStar Pro Middle Ear Analyzer

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

    Other Clearances by Maico Hearing Instruments, Inc.

    K Number Device Name
    K960031 AUDIOFLEX 120
    K954054 MAICO PRODIGY CIC SERIES
    K950637 MAICO IN-THE-EAR MODEL RD-312 CIC
    K946253 MAICO IN-THE-EAR MODEL RD 201
    K931322 KS 5 - CLINICAL AUDIOMETER
    K933291 MAICO BTE MODEL RD-111 AND ITE MODEL RD-312 HEARING AID
    K930112 MAICO MA790 AUDIOMETER
    K926439 MA25 - PORTABLE AUDIOMETER, MODIFICATION
    K931160 SERIES STAR 66 BEKHIND THE EAR HEARING AID
    K931040 MT 80 SP
    Search all 58 clearances from Maico Hearing Instruments, Inc. →