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510(k) Data Aggregation
K Number
K092244Device Name
MA61, MA62, MA63 FAMILY OF PORTABLE AUDIOMETERS
Manufacturer
Date Cleared
2010-03-01
(216 days)
Product Code
Regulation Number
874.1050Why did this record match?
Applicant Name (Manufacturer) :
DIAGNOSTIC GROUP LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The MA61, MA62, and MA63, family of audiometers are a portable line of devices ranging from a one and a half channel, to a full two-channel, air, bone, and speech audiometer. These audiometers are used to screen, test, and diagnose hearing loss.
Device Description
The MA61, MA62, and MA63, family of audiometers are a portable line of devices ranging from a one and a half channel, to a full two-channel, air, bone, and speech audiometer.
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K Number
K063452Device Name
MA 55 MAESTRO
Manufacturer
Date Cleared
2007-03-29
(134 days)
Product Code
Regulation Number
874.1050Why did this record match?
Applicant Name (Manufacturer) :
MAICO DIAGNOSTICS (DIAGNOSTIC GROUP LLC)
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The MA55 system is intended to be used for the detection and diagnosis of suspected hearing loss.
Device Description
Not Found
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