Device Listing 2043132663
Listing Summary#
- Listing key
- 2043132663
- Premarket submission
- K143395
- Device
- 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
- Applicant
- Otodynamics, Ltd.
- Product code
- EWO
- Decision date
- 2015-02-23