Last synced on 19 July 2024 at 11:05 pm

Otoport OAE +ABR Advance, Otoport OAE+ABR DP+TE, Otoport OAE+ABR Screener-Otocheck OAE+ABR, Otocheck OAE+ABR LE, Otocheck ABR Screener-Otodynamics ABR Upgrade Kit

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K143395
510(k) Type
Traditional
Applicant
OTODYNAMICS, LTD.
Country
United Kingdom
FDA Decision
Substantially Equivalent
Decision Date
2/23/2015
Days to Decision
89 days
Submission Type
Summary

Otoport OAE +ABR Advance, Otoport OAE+ABR DP+TE, Otoport OAE+ABR Screener-Otocheck OAE+ABR, Otocheck OAE+ABR LE, Otocheck ABR Screener-Otodynamics ABR Upgrade Kit

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K143395
510(k) Type
Traditional
Applicant
OTODYNAMICS, LTD.
Country
United Kingdom
FDA Decision
Substantially Equivalent
Decision Date
2/23/2015
Days to Decision
89 days
Submission Type
Summary