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510(k) Data Aggregation
K Number
K994033Device Name
HORTMANN ECHOMASTER OAE ANALYZER
Manufacturer
Date Cleared
2000-02-24
(90 days)
Regulation Number
874.1050Why did this record match?
Applicant Name (Manufacturer) :
HORTMANN AG
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Echo Wadu-OAE is a device used by otolaryngologists, audiologists, and nurses for screening hearing in infants and adults to record otoacoustic emissions elicited from either transient or distortion product stimuli.
Device Description
Echo Master- OAE
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K Number
K980505Device Name
HORTMANN AMDIS-OAE OAE ANALYZER
Manufacturer
Date Cleared
1998-04-07
(57 days)
Product Code
Regulation Number
874.1050Why did this record match?
Applicant Name (Manufacturer) :
HORTMANN AG
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Use of the AmDiS otoacoustic Emissions Test Instrument is indicated in any case which requires objective assessment of the inner ear function, e.g., during hearing screening in infants, or for the documentation of ocupational hearing loss.
Device Description
Not Found
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