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510(k) Data Aggregation
K Number
K031978Device Name
AMPLAID A756 SCREENING ADMITTANCE METER
Manufacturer
Date Cleared
2003-07-21
(25 days)
Product Code
Regulation Number
874.1090Why did this record match?
Applicant Name (Manufacturer) :
AMPLAID
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Amplaid A756 Screening Admittance Meter 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.
The unit is intended for use by a qualified/trained audiologist on both adult and pediatric subjects for measurement of acoustic impedance.
Device Description
The Amplaid A756 Screening ADMITTANCE METER performs plane and compensated tympanometry; Programmed and manual stimuli for ipsilateral and contralateral acoustic reflex; Automatic reflex threshold; and Decay measurements.
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