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Found 2 results
510(k) Data Aggregation
K Number
K001058Device Name
AUDIOSCREENER OAE + ABR
Manufacturer
KEDLY, INC.
Date Cleared
2000-06-02
(60 days)
Product Code
EWO
Regulation Number
874.1050Why did this record match?
Applicant Name (Manufacturer) :
KEDLY, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K000184Device Name
AUDIOSCREENER OAE
Manufacturer
KEDLY, INC.
Date Cleared
2000-02-11
(22 days)
Product Code
EWO
Regulation Number
874.1050Why did this record match?
Applicant Name (Manufacturer) :
KEDLY, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
Ask a Question
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