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510(k) Data Aggregation

    K Number
    K992370
    Device Name
    AMPLAID A724 AND A728
    Manufacturer
    Date Cleared
    1999-09-20

    (67 days)

    Product Code
    Regulation Number
    874.1090
    Why did this record match?
    Applicant Name (Manufacturer) :

    AMPLIFON S.P.A.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Amplaid A724 and A728 are Programmable Admittance Meters which can: 1. Evaluate middle ear functions such as otitis media, glue ear, eardrum scar tissues, perform myringotomy status, ossicular chain discontinuity ear canal volume, otosclerosis, stapes fixation. 2. Perform Acoustic reflex test. 3. Determine acoustic reflex threshold 4. Perform reflex decay test. They is intended for use by a qualified/trained audiologist on both adult and pediatric subjects for measurement of acoustic impedance.
    Device Description
    The Amplaid A724 and A728 ADMITTANCE METERS perform plane and compensated tympanometry; Programmed and manual stimuli for ipsilateral and contralateral acoustic reflex; Automatic reflex threshold; and Decay measurements.
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    K Number
    K983915
    Device Name
    AMPLAID A315 AND A319
    Manufacturer
    Date Cleared
    1999-01-29

    (86 days)

    Product Code
    Regulation Number
    874.1050
    Why did this record match?
    Applicant Name (Manufacturer) :

    AMPLIFON S.P.A.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Amplaid Models A315 and A319 are two channel clinical diagnostic audiometers which can perform all audiometric tests normally performed in a clinical situation. It is intended for use by a qualified/trained audiologist on both adult and pediatric subjects for measurement and diagnosis of various types of hearing losses.
    Device Description
    The Amplaid A315 and A319 are two channel clinical diagnostic audiometers which can perform all audiometric tests normally performed in a clinical situation. They provide testing capability for basic evaluation, cochlear versus retrocochlear dysfunction, central dysfunction and non-organic hearing loss. Other diagnostic audiometric tests are: pure tone, Speech, High Frequency, Multifrequency, Bekesy, S.I.S.I., A.B.L.B. (Fowler), D.L.I. (Lüscher), M.L.B., Tone Decay, and M.L.D.(Masking Level Difference).
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    K Number
    K983712
    Device Name
    AMPLAID A311 SERIES
    Manufacturer
    Date Cleared
    1999-01-12

    (83 days)

    Product Code
    Regulation Number
    874.1050
    Why did this record match?
    Applicant Name (Manufacturer) :

    AMPLIFON S.P.A.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Amplaid A311 Series is a two channel clinical diagnostic audiometer which can perform all audiometric tests normally performed in a clinical situation. It is intended for use by a qualified/trained audiologist on both adult and pediatric subjects for measurement and diagnosis of various types of hearing losses.
    Device Description
    The Amplaid A311 Series is a two channel clinical diagnostic audiometer which can perform all audiometric tests normally performed in a clinical situation. It provides testing capability for basic evaluation, cochlear versus retrocochlear dysfunction, central dysfunction and non-organic hearing loss. Other diagnostic audiometric tests are: pure tone, speech, Multifrequency, S.I.S.I., A.B.L.B. (Fowler), D.L.I. (Lüscher), M.L.B., and Tone Decay. The A311 Series comes in two models, both using the same internal circuit board: The AM11 which uses a personal computer as the user interface (communicates via RS232), and the A311, with uses a dedicated front panel keyboard with an LCD display.
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    K Number
    K971740
    Device Name
    AMPLAID MK12
    Manufacturer
    Date Cleared
    1998-03-16

    (308 days)

    Product Code
    Regulation Number
    882.1870
    Why did this record match?
    Applicant Name (Manufacturer) :

    AMPLIFON S.P.A.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Amplaid MK12 is a multi-channel system for electrodiagnosis capable of performing multisensory evoked potential tests including: - Electronystagmography - Visual evoked potentials, - Auditory evoked potentials, and - Electrical (somatosensory) evoked potentials.
    Device Description
    The Amplaid MK12 Multi-channel system for electrodiagnosis consists of a two or four channel signal acquisition system coupled to a microcomputer which can perform signal averaging, storage and display, along with microcomputer controlled multiple mode evoked potential stimulators: auditory, visual, and electrical. A thermal printer is built in, and laser printer connection is supported.
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    K Number
    K974235
    Device Name
    AMPLAID AM50
    Manufacturer
    Date Cleared
    1998-02-10

    (90 days)

    Product Code
    Regulation Number
    874.1090
    Why did this record match?
    Applicant Name (Manufacturer) :

    AMPLIFON S.P.A.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Amplaid AM50 is a Programmable Admittance Meter which can: - Evaluate middle ear functions such as otitis media, glue ear, eardrum scar tissues, . perform myringotomy status, ossicular chain discontinuity ear canal volume, otosclerosis, stapes fixation. - Perform Acoustic reflex test. ● - Determine acoustic reflex threshold . - . Perform reflex decay test. It is intended for use by a qualified/trained audiologist on both adult and pediatric subjects for measurement and diagnosis of various types of hearing losses.
    Device Description
    The Amplaid AM50 ADMITTANCE METER performs plan and compensated tympanometry; Programmed and manual stimuli for ipsilateral and contralateral acoustic reflex; Automatic reflex threshold; and Decay measurements.
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    K Number
    K972959
    Device Name
    AMPLAID MK22
    Manufacturer
    Date Cleared
    1998-02-06

    (179 days)

    Product Code
    Regulation Number
    882.1870
    Why did this record match?
    Applicant Name (Manufacturer) :

    AMPLIFON S.P.A.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Amplaid MK22 is a multi-channel system for electrodiagnosis capable of performing multisensory evoked potential tests including: Electronystagmography Visual evoked potentials, Auditory evoked potentials, and Electrical (somatosensory) evoked potentials.
    Device Description
    The Amplaid MK22 Multi-channel system for electrodiagnosis consists of a two channel signal acquisition system coupled to a microcomputer which can perform signal averaging, storage and display, along with microcomputer controlled multiple mode evoked potential stimulators: auditory, visual, and electrical. A thermal printer is built in, and laser printer connection is supported.
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    K Number
    K972862
    Device Name
    AMPLAID 171S
    Manufacturer
    Date Cleared
    1997-10-31

    (88 days)

    Product Code
    Regulation Number
    874.1050
    Why did this record match?
    Applicant Name (Manufacturer) :

    AMPLIFON S.P.A.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Amplaid 171S is a clinical diagnostic audiometer which can perform all audiometric tests normally performed in a clinical situation. It is intended for use by a qualified/trained audio!ogist on both adult and pediatric subjects for measurement and diagnosis of various types of hearing losses.
    Device Description
    The Amplaid 171S is a one channel clinical diagnostic audiometer which can perform all audiometric tests normally performed in a clinical situation. It provides testing capability for basic evaluation, cochlear versus retrocochlear dysfunction, central dysfunction and non-organic hearing loss. Other diagnostic audiometric tests are: pure tone, and speech.
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    K Number
    K971747
    Device Name
    AMPLAID 460
    Manufacturer
    Date Cleared
    1997-08-05

    (85 days)

    Product Code
    Regulation Number
    874.1050
    Why did this record match?
    Applicant Name (Manufacturer) :

    AMPLIFON S.P.A.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Amplaid 460 is a two channel clinical diagnostic audiometer which can perform all audiometric tests normally performed in a clinical situation. It is intended for use by a qualified/trained audiologist on both adult and pediatric subjects for measurement and diagnosis of various types of hearing losses.
    Device Description
    The Amplaid 460 is a two channel clinical diagnostic audiometer which can perform all audiometric tests normally performed in a clinical situation. It provides testing capability for basic evaluation, cochlear versus retrocochlear dysfunction, central dysfunction and non-organic hearing loss. Other diagnostic audiometric tests are: pure tone, Speech, High Frequency, Multifrequency, Bekesy, S.I.S.I., A.B.L.B. (Fowler), D.L.I. (Lüscher), M.L.B., Tone Decay, and M.L.D.(Masking Level Difference).
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