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AUDX OTOACOUSTIC EMISSIONS MEASUREMENT SYSTEM WITH AUDX I/O FUNCTION

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K111618
510(k) Type
Traditional
Applicant
NATUS MEDICAL INCORPORATED
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
12/28/2011
Days to Decision
201 days
Submission Type
Summary

AUDX OTOACOUSTIC EMISSIONS MEASUREMENT SYSTEM WITH AUDX I/O FUNCTION

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K111618
510(k) Type
Traditional
Applicant
NATUS MEDICAL INCORPORATED
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
12/28/2011
Days to Decision
201 days
Submission Type
Summary