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AUDIOSCREENER OAE + ABR

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K001058
510(k) Type
Traditional
Applicant
KEDLY, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
6/2/2000
Days to Decision
60 days
Submission Type
Summary

AUDIOSCREENER OAE + ABR

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K001058
510(k) Type
Traditional
Applicant
KEDLY, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
6/2/2000
Days to Decision
60 days
Submission Type
Summary