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ALGO Pro Newborn Hearing Screener (ALGO Pro)

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K233649
510(k) Type
Traditional
Applicant
Natus Medical Incorporated DBA Excel-Tech Ltd. (XLTEK)
Country
Canada
FDA Decision
Substantially Equivalent
Decision Date
3/8/2024
Days to Decision
115 days
Submission Type
Summary

ALGO Pro Newborn Hearing Screener (ALGO Pro)

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K233649
510(k) Type
Traditional
Applicant
Natus Medical Incorporated DBA Excel-Tech Ltd. (XLTEK)
Country
Canada
FDA Decision
Substantially Equivalent
Decision Date
3/8/2024
Days to Decision
115 days
Submission Type
Summary